WHO guidelines on ethical issues in public health surveillance

WHO Guidelines on Ethical Issues in Public Health Surveillance P214263_WHO Guidelines on Ethical Issues.indd 1 20/06/17 2:42 PM WHO guidelines on ethical issues in public health surveillance ISBN 978-92-4-151265-7 © World Health Organization 2017 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial- ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, pro- vided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specifi c organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. 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P214263_WHO Guidelines on Ethical Issues.indd 2 20/06/17 2:42 PM 3 Table of Contents Foreword ..................................................................................................................................5 Acknowledgements ..................................................................................................................7 I. Introduction ........................................................................................................................10 II. Background ........................................................................................................................14 Defi ning public health surveillance ..............................................................................14 Surveillance: ethics, law and history ............................................................................16 III. Framing the ethics of surveillance ......................................................................................19 Existing guidelines ......................................................................................................19 Public health ethics .....................................................................................................20 IV. Guidelines .........................................................................................................................24 Guideline 1. Countries have an obligation to develop appropriate, feasible, sustainable public health surveillance systems. Surveillance systems should have a clear purpose and a plan for data collection, analysis, use and dissemination based on relevant public health priorities. ...................................................................25 Guideline 2. Countries have an obligation to develop appropriate, effective mechanisms to ensure ethical surveillance. ..................................................................27 Guideline 3. Surveillance data should be collected only for a legitimate public health purpose. ...........................................................................................................29 Guideline 4. Countries have an obligation to ensure that the data collected are of suffi cient quality, including being timely, reliable and valid, to achieve public health goals. ...............................................................................................................30 Guideline 5. Planning for public health surveillance should be guided by transparent governmental priority-setting. .................................................................31 Guideline 6. The global community has an obligation to support countries that lack adequate resources to undertake surveillance. ..............................................32 P214263_WHO Guidelines on Ethical Issues.indd 3 20/06/17 2:42 PM 4 Guideline 7. The values and concerns of communities should be taken into account in planning, implementing and using data from surveillance. .........................33 Guideline 8. Those responsible for surveillance should identify, evaluate, minimize and disclose risks for harm before surveillance is conducted. Monitoring for harm should be continuous, and, when any is identifi ed, appropriate action should be taken to mitigate it. ....................................................................................................34 Guideline 9. Surveillance of individuals or groups who are particularly susceptible to disease, harm or injustice is critical and demands careful scrutiny to avoid the imposition of unnecessary additional burdens. ............................................................36 Guideline 10. Governments and others who hold surveillance data must ensure that identifi able data are appropriately secured. .........................................................37 Guideline 11. Under certain circumstances, the collection of names or identifi able data is justifi ed. ...........................................................................................................38 Guideline 12. Individuals have an obligation to contribute to surveillance when reliable, valid, complete data sets are required and relevant protection is in place. Under these circumstances, informed consent is not ethically required. .......................40 Guideline 13. Results of surveillance must be effectively communicated to relevant target audiences. ..........................................................................................41 Guideline 14. With appropriate safeguards and justifi cation, those responsible for public health surveillance have an obligation to share data with other national and international public health agencies. ...........................................................................43 Guideline 15. During a public health emergency, it is imperative that all parties involved in surveillance share data in a timely fashion. ................................................44 Guideline 16. With appropriate justifi cation and safeguards, public health agencies may use or share surveillance data for research purposes. .............................45 Guideline 17. Personally identifi able surveillance data should not be shared with agencies that are likely to use them to take action against individuals or for uses unrelated to public health. .........................................................................................46 V. The shifting boundaries of surveillance ...............................................................................48 References ..............................................................................................................................50 P214263_WHO Guidelines on Ethical Issues.indd 4 20/06/17 2:42 PM Foreword 5 Foreword Public health surveillance is the bedrock of outbreak and epidemic response, but it reaches far beyond infectious diseases. It is sometimes called the radar of public health: it allows health offi cials to map disease, spot patterns, identify causes, and target interven- tions. Surveillance, for example, is central to understanding the increasing global burden of noncommunicable conditions. By helping to determine patterns and causes of morbidity and mortality, it can help guarantee access to safe food, clean water, pure air, and healthy environments. Surveillance, when conducted ethically, is the foundation for programs to promote human well-being at the population level. It can con- tribute to reducing inequalities: pockets of suf- fering that are unfair, unjust and preventable cannot be addressed if they are not fi rst made visible. But surveillance is not without risks for participants and sometimes poses ethical dilemmas. Issues about privacy, autonomy, equity, and the common good need to be con- sidered and balanced, and knowing how to do so can be challenging in practice. I am pleased to see WHO leading in this impor- tant area by placing ethics at the heart of pub- lic health surveillance. The WHO Guidelines on Ethical Issues in Public Health Surveillance is the fi rst international framework of its kind, it fi lls an important gap. The goal of the guide- line development project was to to help policy- makers and practitioners navigate the ethical issues presented by public health surveillance. This document outlines 17 ethical guidelines that can assist everyone involved in public health surveillance, including offi cials in gov- ernment agencies, health workers, NGOs and the private sector. I gratefully acknowledge the many experts and WHO colleagues who have made important contributions to this publication. WHO has rightly asserted that public health surveillance, conducted in a manner that anticipates ethical challenges and proactively seeks to reduce unnecessary risks, provides the architecture for social well-being. It is now up to the global community and countries to take up this challenge and implement the guide- lines in their surveillance systems. Dr Marie-Paule Kieny Assistant Director-General Health Systems and Innovation P214263_WHO Guidelines on Ethical Issues.indd 5 22/06/17 2:40 PM Acknowledgements 7 Acknowledgements This document was prepared by the WHO Global Health Ethics team, led by Andreas Reis and coordinated by Abha Saxena of the Depart- ment of Information, Evidence and Research in the cluster of Health Systems and Innovation. WHO extends special thanks to the co-chairs of the WHO Guidelines Development Group: Amy L. Fairchild, Texas A&M University School of Public Health, USA, and Co-director for the Columbia University WHO Collaborating Cen- tre for Bioethics, and Ali Akbar Haghdoost, Kerman University of Medical Sciences, Islamic Republic of Iran. Amy Fairchild was lead writer and chief editor. Ali Akbar Haghdoost contributed technical text and was responsible for ensuring the accuracy of the document with regard to the operation of surveillance systems. Angus Dawson and Lisa Lee contributed substantially to formulating the guiding principles and discussions. Calvin Ho Wai Loon provided core text on legal systems and issues. Jennifer Gibson contributed text on accountability and governance. Ronald Bayer, who was Chair of the Network of Collaborating Centres for most of the duration of this project, played a pivotal editorial role, with Ross Upshur and Carla Saenz. Ronald Bayer, Michael Selgelid, and Angus Dawson substantively addressed comments from the Guideline Development Group and external reviewers. Michael Selgelid, Andreas Reis, Amy Fairchild and Ronald Bayer prepared grant proposals to fund the work. WHO gratefully acknowledges the contribution of the WHO Guidelines Development Group, which shared extensive knowledge, original text and comments on the document. All are also co-authors of the document: Kokou Agoudavi, Ministry of Health, Togo; Jimoh Amzat, Usmanu Danfodiyo Univer- sity, Nigeria; Ronald Bayer, Columbia Univer- sity Mailman School of Public Health, USA; Philippe Calain, Médecins Sans Frontières, Switzerland; Yali Cong, Peking University Health Science Centre, China; Angus Dawson, University of Sydney, Australia; Claire Gayrel, University of Namur, Belgium; Jennifer L. Gibson, Joint Centre for Bioethics, Univer- sity of Toronto, Canada; Kenneth Goodman, University of Miami, USA; Vijayaprasad Gopichandran, Tamil Nadu School of Public Health, India; Einar Heldal, Institute of Public Health, Norway; Calvin Ho Wai Loon, National University of Singapore Centre for Biomedical Ethics, Singapore; Hussain Jafri, Council for Alzheimer’s, Pakistan; Lisa M. Lee, Presidential Commission for the Study of Bioethical Issues, USA; Sergio Litewka, University of Miami, USA; Mina Mobasher, Kerman University of Medical Sciences, Islamic Republic of Iran; Keymanthri Moodley, Stellenbosch University, South Africa; Boateng Okyere, University of Ghana, Ghana; Maria Consorcia Quizon, Training programs in Epidemiology and Public Health Interventions Network, Philippines; Pathom Sawanpany- alert, Food and Drug Administration, Thailand; P214263_WHO Guidelines on Ethical Issues.indd 7 20/06/17 2:42 PM 8 Acknowledgements Michael Selgelid, Monash University, Australia; Ross Upshur, University of Toronto, Canada; Effy Vayena, University of Zurich, Switzerland. The Global Network of WHO Collaborating Centres for Bioethics and their members are gratefully acknowledged. WHO thanks the support provided by various observers: Ehsan S Gooshki, Tehran University, Islamic Republic of Iran; Katherine Littler, Wel- come Trust, United Kingdom; Debra Mosure, Centers for Disease Control and Prevention, USA; Patricia Sweeney, Centers for Disease Control and Prevention, USA; and Hans van Delden, Utrecht University Medical Centre, Netherlands. The support and contributions of two consul- tants is greatly appreciated: Carl H. Coleman, Seton Hall Law School, USA, and Michele Loi, Swiss Federal Institute of Technology, Switzerland. This guidance document benefi ted from the work of a literature review group, comprising: Corinna Klingler, Ludwig Maximilian University Munich, Germany (lead); Diego S. Silva, Simon Fraser University, Canada; Daniel Strech and Christopher Schürmann, Hannover Medical School, Germany; and Michael Vaughn, Colum- bia University School of Public Health, USA. WHO’s Global Health Ethics team extends thanks to the WHO internal steering group for its invaluable advice on development of the guidelines: Isabel Bergeri, Marie-Charlotte Bouesseau, Somnath Chatterji, Joan Helen Dzenowagis, Sergey Romualdovich Eremin, Jesus Maria Garcia Calleja, Margaret Orunya Lamunu, Anais Legand, Ahmed Mandil, Tim Nguyen, Bruce Jay Plotkin, Manju Rani, Leanne Margaret Riley, Pascal Ringwald, Carla Saenz Bresciani, Nahoko Shindo, and Matteo Zignol, as well as WHO colleagues Ronald Johnson, Vasee Moorthy, Mahnaz Vahedi, Amin Vakili, and Jihane Tawilah. The document also benefi ted from the work of an external review group, comprising: Larry Gostin, Georgetown Law Center, USA; Philip Zucs, Gaetan Guyodo, Marieke van der Werf, European Centre for Disease Prevention and Control, Sweden; Nijuan Xiang, Public Health Emergency Centre, Centers for Disease Control, China; Martyn Kirk, College of Medicine, Biol- ogy and Environment, Australian National Uni- versity, Australia; Thilaka Chinnaya, Ministry of Health, Malaysia; Mohammed Ben Ammar, for- merly at the Ministry of Health, Tunisia; Lorna Luco, Universidad del Desarollo, Institute of Bioethics, Chile; and Preet Dhillon and Shifalika Goenka, Public Health Foundation, India. Special thanks are extended to former interns of the Global Health Ethics team who con- tributed to this document: Nicholas Aagaard, Sara Birch Ares, Hannah Coakley, Christine Fisher, Antonia Fitzek, Theresa Fuchs, Sandrine Gehriger, Christina Heinicke, Sophie Hermann, Katalin Hetzelt, Felicitas Holzer, Patrik Hummel, Helene Maree Jacmon, Euzebiusz Jamrozik, Selena Knight, Pat McConville, Sarah McNeill, Jan Nieke, Julia Pemberton, Maansi Shahid, Alexander Shivarev, and Michael Vaughn. WHO gratefully acknowledges Phuong Bach Huynh, School of Public Health, Texas A&M University, for the design of the cover page. Preparation of this guidance document would not have been possible without the generous support of the Fondation Brocher, Switzer- land; Monash-Warwick Alliance Seed Fund Scheme project on “Ethics of Public Health Security”, Australia; Wellcome Trust, United Kingdom; and the Institute for Bioethics and Health Policy, University of Miami, USA. P214263_WHO Guidelines on Ethical Issues.indd 8 20/06/17 2:42 PM 9 The WHO Strategic Health Operations Centre (SHOC) May 3, 2009. Source: WHO /Christopher Black P214263_WHO Guidelines on Ethical Issues.indd 9 20/06/17 2:42 PM 10 Introduction I. Introduction Disease surveillance has been a basic public health activity since the late nineteenth century (see Table 1). It is the foundation for initiatives to promote human well-being at the popula- tion level. Public health surveillance is the bed- rock of outbreak and epidemic response, but it reaches far beyond infectious diseases. It can contribute to reducing inequalities: pockets of suffering that are unfair, unjust, and prevent- able cannot be addressed if they are not fi rst made visible (1). It is central to understanding the increasing global burden of noncommuni- cable conditions. By helping to determine pat- terns and causes of morbidity and mortality, public health surveillance can help guarantee access to safe food, clean water, pure air, and healthy environments. Continuous envi- ronmental surveillance may not only identify concerns but also trigger alerts. Occupational disease surveillance can identify workplace exposures and lead to regulation. Surveillance can help create accountable institutions by providing information about health and its determinants. It can provide an evidentiary basis for establishing and evaluating public health policy. Surveillance, for example, will be central to the achievement of the United Nation’s Sustainable Development Goals. The availability of the results of surveillance enables and promotes policy choice. Thus, access to surveillance information can serve as a tool for advocacy when the results are Table 1. Dimensions of public health surveillance Scope Communicable diseases Noncommunicable diseases Environmental factors Risk factors and risk markers Health system Demographic variables Health-related events (e.g. food and drug safety, vaccine reactions) ↓ Objectives Early detecting and warning of epidemics Trend and spatial analyses Risk detection Generating hypotheses Monitoring of health system performance Evaluation of control measures Policy analysis ↓ Data collection tools Registries Case reports Repeated surveys Bio-banks Secondary data sources Population-based (universal or sentinel sites) Social media ↓ Types of analysis Estimation of incidence or prevalence Measurement of associations Assessment of trends Assessment of spatial patterns Data mining ↓ Uses Policy change Structural intervention Case or epidemic detection Testing of hypotheses Implementation research Quality assurance Source: A.A. Haghdoost P214263_WHO Guidelines on Ethical Issues.indd 10 20/06/17 2:42 PM Introduction 11 shared with populations and policy-makers in a timely, appropriate manner. Yet surveillance has been the subject of some- times bitter controversy. Public health sur- veillance may limit not only privacy but also other civil liberties. For example, surveillance may trigger mandatory quarantine, isolation, or seizure of property during an epidemic (2). When surveillance involves name-based reporting (that is, reporting by name), it can, to the extent that populations are made aware, trigger profound concern about intrusions on privacy, discrimination, and stigmatization. Name-based reporting can also seriously harm people and property, as is seen when mob reactions supersede care, compassion and the effective rule of law. Concern is compounded in the absence of trust that the public health system will keep names secure or will release aggregated data and related information (referred to simply as “data” from this point forward, as records contain information that varies in type and scope) in a sensitive manner (2). In some countries, the HIV/AIDS pandemic sparked controversy about tracking by name those carrying the virus, but, even when con- fi dentiality was assured, when details of risky behaviour and affected populations became public, groups like gay sex workers and inject- ing drug users experienced social harm such as discrimination and stigmatization. Because of these concerns, the HIV/AIDS epidemic spurred ethical and regulatory guidelines at both national and international levels that could be used in planning, collecting and then using personal and aggregated data. Just as often, however, failure to conduct public health surveillance has generated political and ethical controversy because of concern that “what doesn’t get counted doesn’t count”. Environmental and occupational health advocates, for example, have long made this argument. Even for events deemed critically important, yawning gaps in surveillance remain. The 2014–2016 Ebola virus disease crisis dramatically underscored the potentially devastating consequences of a lack of capacity to monitor the incidence and spread of disease. An effective public health or clinical response can be seriously hampered by the absence of such data. But if Ebola virus disease is a high- profi le example of the costs of inadequate systems and the importance of support from the global community for vital surveillance, many other occupational and environmental exposures – like asthma, silicosis and condi- tions related to exposure to arsenic or lead – go uncounted in both high- and low-income countries. Some commentators have argued that, too often, only when a public health crisis becomes a “threat to international peace and security” does surveillance become a priority for wealthy countries (3). But even when sur- veillance is a priority, fragmented, unlinked or consolidated data sets remain a problem for their effective use for public health purposes. While surveillance is often conducted without public knowledge or concern when the risk for stigma, discrimination or perpetuation of inequity is high, surveillance inevitably involves confl icts of values and judgements about how to advance public health goals without harm- ing individuals or groups in society. Thus, the priorities and the distribution of resources for surveillance merit public debate, not only within societies but among global communi- ties. Despite landmark international guidelines on the ethics of research, including epidemio- logical studies, and specifi c ethical guidelines for surveillance of particular diseases and/ or in particular countries, there has been no international ethics framework to guide pub- lic health surveillance systems in general that spans infectious diseases, noncommunicable diseases (NCDs), disease outbreaks, environ- mental and occupational exposures, and even national borders. The Council for International P214263_WHO Guidelines on Ethical Issues.indd 11 20/06/17 2:42 PM 12 Introduction Organizations of Medical Sciences (CIOMS), the World Medical Association and others have identifi ed this gap (4). It is crucial to have ethical guidance as a baseline for judging public health surveillance for all diseases and exposure across national borders. The fragmented, disease-specifi c nature of international guidance is not surprising, given the uneven, incomplete state of public health surveillance in both high- and low-resource settings and different national and subnational mandates for surveillance in different legal sys- tems. It is imperative to address the ethics of public health surveillance in a way that cuts across conventional boundaries, for a number of reasons. Public health operates in an era of global health threats, such as AIDS, severe acute respiratory syndrome (SARS), infl uenza, Ebola virus disease, Zika virus infection, obesity and coronary heart disease. Given the zoonotic ori- gin of many of the conditions, surveillance will increasingly involve monitoring the animal– human interface. For example, surveillance of food and animal feed for pathogens must be linked to surveillance for the same pathogens in humans. Surveillance is conducted in a context in which there have been signifi cant advances in the capacity to collect and share data from previ- ously unimagined sources, such as social media or geospatial mobile phone data. There have been parallel technological leaps in possibili- ties for identifying disease; genetic analysis, as just one example, allows rapid identifi cation of pathogens or pathogenic strains. At the same time, inequalities within societies and within the global community have become more marked. There are growing gulfs in the capacity of dif- ferent nations and locales to take advantage of technological change. Civil confl icts in dif- ferent countries inevitably trigger health crises that draw the attention of both United Nations agencies and humanitarian organizations. Cri- sis situations, in turn, deepen inequalities and create additional barriers to surveillance and intervention in confl ict zones (3). This remarkable epidemiological, social, eco- nomic, political and technological global landscape makes it imperative to fi ll the gap in international guidelines and to address the ethics of public health surveillance explicitly. That is the aim of these international guide- lines on the ethics of public health surveillance. They were prepared by an international group of experts in surveillance, epidemiological research, bioethics, public health ethics and human rights. The authors of these guidelines represent leading research institutions and also nongovernmental organizations (NGOs) either involved in surveillance or representing groups and populations with a vital interest in both the benefi ts and burdens of surveillance. The authors also represent countries in both the south and north, with different political systems, social values and priorities. The guidelines were prepared in collaboration with the global network of WHO Collaborating Dog and pig vendor at market day, Atsabe, Ermera. Source: WHO / SEARO /Joao Soares Gusmao P214263_WHO Guidelines on Ethical Issues.indd 12 20/06/17 2:42 PM Introduction 13 Centres for Bioethics, which initiated the proj- ect. They also drew on the technical support of the US Centers for Disease Control and Prevention to ensure that the guidelines took account of the actual procedures for and cost of data collection, analysis and dissemina- tion and can thus reasonably be used. The guidelines are based on a systematic literature review of relevant research and grey literature in accordance with the WHO Handbook for Guideline Development (5). The goal of the guideline development project was to identify key ethical considerations to guide resolution of controversies that may arise in surveillance, which itself is an ethical obli- gation of governments. Specifi c ethical issues are addressed in contexts that differ in terms of culture, values, resources, political traditions and institutional structures, with sometimes very different expectations for the impor- tance of individual rights, community solidar- ity and/or the good of society. The guidelines also address challenges that arise in contexts characterized by persistent injustice and/ or repeated violation of human rights. These guidelines cannot therefore provide concrete answers to all the diffi cult questions raised by public health surveillance. Rather, on the basis of a set of core considerations for the ethics of public health, the guidelines establish the duty to conduct surveillance, share data and engage communities transparently, while recognizing the limits of that mandate. The 17 guidelines should not be read in isolation from each other or from the discussion of each of them. They jointly lay out the issues that those involved in surveillance (including offi cials in government agencies, health workers involved in surveil- lance, NGOs and the private sector) should consider and weigh carefully when making decisions about the collection, analysis, shar- ing, communication and use of surveillance data. While the guidelines do not specify a mechanism for oversight, the conclusion is that, in view of the overarching imperative to conduct surveil- lance, analyse the data and act on the results, responsibility and accountability must ultimately be based on a sustainable, practical mechanism for ensuring that the ethical challenges posed by public health surveillance are anticipated and addressed systematically and transparently. Countries should ensure implementation of these guidelines and monitor it regularly. P214263_WHO Guidelines on Ethical Issues.indd 13 20/06/17 2:42 PM 14 Background II. Background Defi ning public health surveillance Some countries defi ne surveillance narrowly, others quite broadly. These guidelines cover surveillance as broadly understood. In the simplest formulations, surveillance is defi ned as “continued watchfulness” (6) or “the mon- itoring of events in humans, linked to action” (7). WHO generally defi nes surveillance as “the continuous, systematic collection, analysis and interpretation of health-related data needed for the planning, implementation, and evalu- ation of public health practice” (8). Health data are those pertaining to communicable and NCDs, injuries and conditions and their related risks and determinants. For infectious disease outbreaks (and events that suggest a “potential for international disease spread”), the International Health Regulations (2005) (IHR) defi ne surveillance as “the systematic on-going collection, collation and analysis of data for public health purposes and the timely dissemination of public health information for assessment and public health response as necessary” (9). Understanding of public health surveillance differs considerably from country to country. Although surveillance is usually described as systematic or continuous, not all countries, institutions or scholars single out the rou- tine nature of public health surveillance but rather emphasize the purpose and function of data collection (see Table 1). Likewise, although disease and injury always fi gure centrally, some defi nitions include determi- nants of important public health events (10) and environmental conditions that affect health (11). Vital registration of events like births and deaths, although often not specif- ically described as part of a “public health” surveillance system, is often considered to be surveillance. Although international agencies often spon- sor, subsidize and oversee national surveys in low- and middle-income countries to track trends in risk factors or health outcomes, national public health authorities are usu- ally responsible for public health surveillance systems and activities. The IHR, however, recognizes surveillance data from beyond the formal channels of reporting, including unof- fi cial or informal sources, provided that they meet standards of reliability and validity. For some organizations and experts, only those activities in which the purpose of data gather- ing has been defi ned in advance and, indeed, in which the questions driving data collec- tion are set in advance meet the defi nition of public health surveillance (12). The Australian Department of Health uses a broader epi- demiological defi nition of surveillance: the continuing scrutiny of all aspects of the occur- rence and spread of disease that are pertinent to effective control (13). Some designations explicitly exclude case-fi nding (and subsequent testing and treatment), public health investiga- tions and epidemiological research (12), while others consider that “use of epidemiological Health worker collecting records and fi lling out surveys with the inhabitants of Salto, Uruguay. Source: WHO/TDR /Sebastian Oliel P214263_WHO Guidelines on Ethical Issues.indd 14 20/06/17 2:42 PM Background 15 Bedside computer in the diabetic ward of the King’s Hospital, London, 1970s. Source: WHO /Peter Larsen P214263_WHO Guidelines on Ethical Issues.indd 15 20/06/17 2:43 PM 16 Background information” falls within the scope of surveil- lance (14). A  surveillance system may thus cover not only infectious diseases and involve not only continuous data collection but may also include focused epidemiological studies; inspection of hazardous conditions or broad oversight of the potential danger posed by food, water or the environment; and screen- ing at workplaces or in health establishments. Table 1 gives an overview of the activities that fall within public health surveillance. While there may be broader and narrower defi nitions, the understanding of surveillance is that data are collected with the intent of enabling public health action, whether direct intervention, priority-setting, resource alloca- tion or advocacy. “Knowing about the health of a community,” noted one group of surveil- lance specialists, “is the fi rst step to making improvements that support healthy behaviours, identify and address unusual health events, and prevent and treat disease and injury.” (12) In addition to linking surveillance to action to achieve some goal, almost all countries, institu- tions and experts underscore the importance of communicating surveillance results to those “who need to know”, including the public, policy-makers, national and international sci- entifi c communities, programme planners, public health authorities, medical institutions and funding agencies, to enable intervention, sustainable development or advocacy. The landscape of public health practice is also changing rapidly with regard to the kind of data to which public health agencies have routine access. In some settings, data are recorded by hand and stored on paper; in oth- ers, they are collected, stored and shared via sophisticated electronic systems. The era of “big data,” as discussed in section V, may hold enormous potential for the future of public health surveillance, broadly understood, and has already raised vexing ethical questions. In  some jurisdictions, surveillance systems could soon be linked directly to electronic health records. Interoperability between pub- lic health surveillance data sources and clini- cal practice is within reach, in both the public and the private health care sectors (15). Public health data can be used to inform automatic decision-support systems or computational tools to trigger alerts and warnings. Research has shown, further, that geospatial mobile phone data could accurately describe and pre- dict the movement of individuals and thereby the spread of diseases like malaria and H1N1 infl uenza (16-18). These guidelines defi ne public health surveil- lance systems broadly, building on the general WHO defi nition of continuous, systematic col- lection, analysis, interpretation, and sharing of health–related data for advocacy and for plan- ning, implementing, and evaluating public health practices. Even if systems are operative, however, new, focused studies are required to respond to epidemiological threats. Further, public health surveillance systems not only rely on but may also inform and improve clinical practice. Surveillance: ethics, law and history Nation states have established surveillance sys- tems that differ in scope and purpose. Interna- tional law and regulation have been important means of ensuring at least a basic level of public health surveillance in all countries. In 1969, the WHO Member States adopted the IHR, a revision and consolidation of the Inter- national Sanitary Regulations, as the frame- work for strengthening health security in an increasingly interconnected world. They came into force in 1971 (19). The IHR impose a legal obligation on all Member States to have cer- tain core public health capacities, including surveillance and data collection, with the goal P214263_WHO Guidelines on Ethical Issues.indd 16 20/06/17 2:43 PM Background 17 of preventing, controlling or responding to the international spread of disease. Experience with the SARS crisis of 2003 led the World Health Assembly to adopt a signifi cant revision of the IHR on 23 May 2005 (9). While the IHR had originally focused on a short, fi xed list of communicable diseases, the revised reg- ulations – IHR (2005) – allow fl exibility to target any disease that may constitute a public health emergency of international concern. They also establish an obligation to create core capacity for surveillance and outbreak response to dis- ease and “public health events”. As of Novem- ber 2014, however, 48 countries had failed to communicate their capacity or plans, and another 81 had asked for extensions to com- ing into compliance (20). The recent outbreak of Ebola virus disease revealed that many countries had not satisfi ed their obligations under the IHR; only 64 countries – one third of those bound by the IHR – “had achieved these core capacities”. Nevertheless, while all countries are required to comply with the IHR, limited resources and political instability can pose obstacles to surveillance, and it may not be possible to overcome these obstacles with- out international assistance. The IHR (2005) are limited in the sense that they provide mainly a framework for gover- nance in addressing “public health emergen- cies of international concern”. The framework is neither for constructing comprehensive surveillance systems nor for grappling with the ethical issues posed by surveillance sys- tems and practices. International regulation, like national law and regulation, is an impor- tant tool that establishes a duty to conduct surveillance while also setting limits on that practice. What is legal, however, is not always ethical. Ethics is an essential tool for critically evaluating law, regulation and practice and for addressing the value confl icts that may be posed by surveillance. Local and national surveillance systems emerged in the nineteenth century, and almost all comprised physicians’ case reports. The data were initially used almost exclusively to document either social progress or misery (21). At the heart of the most bitter battles over individual rights and population health, how- ever, were surveillance measures that made intervention at the level of individuals possible, with the discovery of germs and the realization that many diseases were spread from person to person. Interventions based on communica- ble disease reports were sometimes welcomed (leading to referral to clinics, provision of food and clothing) but were sometimes a cause of alarm (when leading to mandatory vaccination or treatment, quarantine or deportation). Offi - cial morbidity reports were usually protected against public disclosure by law, regulation, and practice. Surveillance was also the basis for population health measures, such as the pasteurization of milk, regulation of food and drug manufacture, housing reform and other measures that addressed the structural causes of disease. Resistance to such measures, largely on the part of independent and incor- porated businesses, was often framed as an issue of individual rights. Physicians, worried about interference with their patients and use of their time, often resented, resisted or simply ignored man- dates for reporting. But not all monitoring of morbidity and mortality required iden- tifi cation of cases by name. Reporting of sexually transmitted diseases, for example, was often done by code instead of name in industrialized countries (21). Contact tracing, of course, required names, but most physi- cians kept the index case anonymous when patients cooperated by providing the names of sex partners and adhering to treatment. Whether names were necessary or whether informed consent was required often framed debates as surveillance was extended, over P214263_WHO Guidelines on Ethical Issues.indd 17 20/06/17 2:43 PM 18 Background the course of the twentieth century, to NCDs such as cancer, diabetes and stroke and to occupational exposures, substance use, road accidents, injuries, vaccination status and vaccine reactions (22). During the twentieth century, it was often people affected by a disease or condition who challenged the need for surveillance; but, just as often, the story of surveillance has been one in which affected groups have demanded the “right to be counted” (22). NCD surveil- lance, in contrast to infectious disease surveil- lance, has been underfunded and “woefully inadequate,” even in high-income countries (23). Workers exposed to toxic hazards and citizens vulnerable to environmental pollut- ants have sometimes joined social movements as a means of gaining both attention and the resources necessary for surveillance; however, the more common story is that chronic disease threats, particularly those of vulnerable popu- lations, remain invisible. Global crises often expose systemic challenges that are insuffi ciently addressed. Undocu- mented migrants with tuberculosis are still not included in statistics submitted to WHO by some countries (24, 25), but it would be a mistake to assume that the only challenges are the absence of surveillance or under-reporting. Tuberculosis surveillance data, for instance, were critical for determining levels of funding from the Global Fund to Fight AIDS, Tubercu- losis and Malaria. Surveillance staff sometimes found themselves under high pressure to reach what some criticized as unrealistic targets. They had to choose between showing “good” results or losing their jobs, adversely affecting the quality of data in some settings (26, 27). These guidelines are based on the understand- ing that surveillance is so fundamental a public health practice that its advancement cannot depend on crises or citizen protests to make the case for tracking disease for the sake of public health. While these guidelines represent a call to action, it is not a call to unrestrained action. Rather, public health surveillance, con- ducted in a manner that anticipates ethical challenges and proactively seeks to reduce unnecessary risks, provides the architecture for social well-being. Industrial pollution. Moscow, Russia. Source: WHO /Sergey Volkov P214263_WHO Guidelines on Ethical Issues.indd 18 20/06/17 2:43 PM Framing the ethics of surveillance 19 III. Framing the ethics of surveillance Existing guidelines Limited academic literature on the practice of public health surveillance addresses the major ethical questions that arise in data collection; when the data are actually stored, used and shared; and data dissemination. The academic literature is (28), however, no substitute for guidelines that go beyond current disease- specifi c, national recommendations (29). In the decades since the Second World War, both international and national bodies have proposed ethical principles, guidelines and laws to govern research with human sub- jects. In response to egregious harm infl icted on individuals coerced into clinical research, new codes of ethics uniformly prioritized indi- vidual self-determination and emphasized the importance of informed consent for research, while acknowledging that it would hardly be straightforward in complex situations to bal- ance the protection of human research sub- jects against the social benefi t of the research. In the practice of clinical ethics, autonomy assumed a place of singular importance, rep- resenting a fundamental change in a moral world view (30-33). In its “International guidelines for ethical review of epidemiological studies” in 1991, CIOMS acknowledged that existing guidance focused on “patients and individual subjects” was not suffi cient for studies involving “groups” of people. After considerable controversy, a con- sensus emerged: CIOMS stressed the impor- tance of the principles of research ethics fi rst set out in the Nuremberg Code but recognized that application in the epidemiological context would require fl exibility (34). The tradition that developed was one in which research ethics committees could waive a requirement for informed consent when the risk posed by epidemiological research was “no more than minimal” and obtaining consent would make the research “impracticable” (34). While public health surveillance may share methodological strategies with epidemiologi- cal research, it is not simply another form of research. In  surveillance a  community is the subject of concern. That surveillance is one of the responsibilities of public health was rec- ognized in 1991 by CIOMS, which described surveillance in emergency outbreak situations as clearly requiring exemption from ethi- cal review and oversight. In dire situations, surveillance could not “await the formal approval of an ethical review committee” (34). Emergencies, however, accounted for only a small part of surveillance activities. Not until its 2009 revision did CIOMS guide- lines explicitly support continuous case-based public health surveillance (in the absence of informed consent). The revision stated, “Several considerations support the com- mon practice of requiring that all practitio- ners submit relevant data [to public health surveillance registries]: the importance of having comprehensive information … about an entire population, the scientifi c need to include all cases in order to avoid undetect- able selection bias and the general ethical principle that burdens and benefi ts should be distributed across the population.” (35) This position echoed that of the Nuffi eld Council on Bioethics in the United Kingdom. In 2007, the Council warned against allowing individuals to opt out of reporting, arguing, “We are aware of several examples [in which] consent requirements have or could have had serious negative consequences.” (36) Despite this sweeping endorsement of mandatory nominative case reporting without consent, the Council underscored the inevitability of P214263_WHO Guidelines on Ethical Issues.indd 19 20/06/17 2:43 PM 20 Framing the ethics of surveillance making ethical judgements about the limits of surveillance (36). Neither CIOMS nor the Nuffi eld Council pro- vided more guidelines on ethics for public health surveillance, nor did they resolve the vexing problem of how to distinguish surveil- lance from research on human subjects. Are there morally relevant differences between public health surveillance and research (4, 37)? Do they require different general guide- lines and oversight mechanisms? Does, indeed, public health surveillance require any kind of formal guidelines or continuous over- sight? Drawing the line between research and surveillance – or between research and other forms of vital social inquiry such as quality improvement, implementation research, oral history or even journalism – has been chal- lenging, but defi nitional solutions have (to date) proved inadequate (38, 39). Accord- ingly, a leading group of surveillance experts underscored the need “to move past the formal demarcation between research and practice” (29). These guidelines seek to do so, not by laying out new defi nitions but by setting into bold relief both the centrality of public health surveillance to population well- being and the need for appropriate ethical guidance and review – that is, for a para- digm of accountability that responds to the demands of public health and that is distinct from the systems that have governed research for half a century. Public health ethics The discipline of public health ethics has developed rapidly during the past two decades. Its central focus has been on articu- lating and exploring the ethical issues that arise in the pursuit of population health. This has resulted in a focus on concepts such as the common good, equity, solidarity, reci- procity, and population well-being. This is not to say that more individual values such as autonomy, privacy, and individual rights A crowd at a community event to launch a vaccination campaign. Source: WHO /Garry Smyth P214263_WHO Guidelines on Ethical Issues.indd 20 20/06/17 2:43 PM Framing the ethics of surveillance 21 and liberties are not also important ethical considerations; however, these more “social” or “public” values are refl ected in related yet not wholly overlapping concepts that capture the broad importance of community and the affi rmative duty to act. Some in the fi eld use the language of solidarity (40), drawing on the communitarian tradition in public health (41); others describe the mutual obligations of reciprocity (42). The Nuffi eld Council on Bioethics sought to capture the duties and responsibilities of government in relation to public health by the concept of “steward- ship” (36). After a careful review, refl ection and delibera- tion, the WHO Guidelines Development Group determined that the following ethical consid- erations are of particular importance for public health surveillance. They represent the back- bone of the guidelines: Common good: Surveillance is widely acknowledged to be a public good (43), and some of the benefi ts it pro- vides cannot be subdivided into indi- vidual private benefi ts because they are fundamentally shared (41, 44). Surveil- lance is justifi ed, fundamentally, as a requirement for the good of all. With- out adequate oversight by public health bodies and the participation of individ- uals and communities, the shared ben- efi ts of surveillance are at risk. There is a complex literature on economics and moral philosophy that seeks to defi ne and distinguish the terms “public good”, “public goods,” and “the com- mon good” (45). After careful delibera- tion, the committee adopted the term “the common good” to capture the notion of public goods more broadly conceived than in the narrow economic sense. Equity: Public health ethics is centrally concerned with the idea of equity. It is well established that social inequality has adverse effects on health (46). Not all inequality is within human control or is morally relevant. Morally prob- lematic inequality is commonly referred to as inequity. A just or fair society will attempt to provide equitable conditions for humans to fl ourish, with health as a central component. Equity some- times requires that the most vulnerable people receive what may appear to be disproportionate resources: that is, the unfair distribution of risks requires addi- tional resources to balance the scales. Public health surveillance can further the pursuit of equity by identifying the particular problems of disadvantaged populations, including global communi- ties, providing the evidence for focused health campaigns and identifying the basis of unfair differences in health. Respect for persons: Public health eth- ics is concerned with the rights, liberty, and other interests of individuals as well as overall population well-being. When- ever possible, individuals should be involved in decisions that affect them. In some cases, individuals should be free to make their own choices; in other cases, when population-level interven- tions may be necessary, individuals can be consulted and involved in decision- making. But many individuals (such as young children) cannot make their own choices, and the State has an obligation to protect them and promote their long- term health interests. Undertaking pub- lic health surveillance is, itself, arguably an expression of respect for persons. This further requires ensuring that data about individuals and groups are pro- tected and risks for harm are minimized P214263_WHO Guidelines on Ethical Issues.indd 21 20/06/17 2:43 PM 22 Framing the ethics of surveillance to the greatest possible extent. Finally, surveillance further engenders respect for persons by making protection or amelioration possible. Good governance: Although good gov- ernance is not an ethical principle but rather a political aspiration, it is subject to a number of ethical considerations. To ensure that the ethical challenges posed by public health action are addressed systematically and fairly, governance mechanisms must be accountable and open to public scrutiny. Although pro- tection of the common good must draw on the best available evidence, decisions will have to be made in the face of uncertainty. Accountability, transparency and community engage- ment are means of justifying public policy structures that promote respect for persons, equity, and the common good. Transparency requires that poli- cies and procedures for surveillance be communicated clearly and that affected individuals or communities be aware of any decisions concerning them. Trans- parency also requires public reporting of the results of surveillance (in ano- nymized or aggregated form). Without such knowledge, communities cannot be empowered to demand government action or to protect themselves in the absence of alternatives. These are not the only relevant ethical consid- erations with regard to the nature of surveil- lance programmes and practice but the ones considered central to making decisions in the specifi c context of public health surveillance by those involved in development of these guidelines. While over the past few decades the global discourse on research ethics has come to an agreement on how best to frame issues, public health ethics has not reached such a juncture. Thus, even in documents explicitly grounded in public health ethics, differences in language and emphasis remain. This docu- ment is one of three recent WHO-sponsored initiatives to develop ethical frameworks for disease control. Building on the original “Guidance on ethics of tuberculosis preven- tion, care and control” in 2010 (47), the “Ethics guidance for the implementation of the End TB Strategy” (48) addresses the most critical challenges to reducing the number of deaths from tuberculosis by 95% by 2030 and the number of new cases by 90% between 2015 and 2035. The “Guidance for managing ethical issues in infectious disease outbreaks” (49) in 2016, in response to the outbreak of Ebola virus disease in West Africa in 2014–2015, underscored the importance of providing ethics guidance beyond “a spe- cifi c pathogen in isolation” to “cross-cutting ethical issues that apply to infectious disease outbreaks generally”. The three projects obviously have important continuity. All, for example, emphasize equity, justice, and the common good (sometimes expressed as “stewardship” or “reciproc- ity”). All stress the importance of respecting the dignity of persons (sometimes emphasiz- ing autonomy or privacy). Accountability and the importance of good governance either explicitly or implicitly informs all three. They also have relevant differences that refl ect the subject of each. The tuberculosis guidelines, for example, address the problem of drug- resistant disease and thus emphasize the harm principle. The guidelines on infectious disease outbreaks, framed as they were by concern for groups in conditions of tremendous vulner- ability and the ways in which outbreaks can become crises, further amplifi ed by fear and distrust, places greater emphasis on human rights. Given the need to make decisions in P214263_WHO Guidelines on Ethical Issues.indd 22 20/06/17 2:43 PM Framing the ethics of surveillance 23 the face of uncertainty, they also stress utility, proportionality and effi cacy. The ethical considerations outlined above and repeated and amplifi ed in the guidelines that follow are, in the estimation of this commit- tee, central to justifi cation of surveillance as a core activity, beyond outbreaks or infectious disease situations. They must be applied in situations that may vary in fundamental ways. The guidelines recognize that trade-offs of values are sometimes inevitable. The local tra- ditions and priorities in countries may some- times result in a different balance between competing values and priorities. It is important to stress, however, that not all trade-offs are morally acceptable. Local, national, or regional circumstances may be characterized by gross injustice or violations of human rights. In these contexts, rather than serving the common good, public health surveillance may be used as an instrument for violation of respect for persons, equity, and justice. In countries where sex work is a criminal offense, for example, HIV surveillance can be used for oppression. Likewise, an occupational disease surveil- lance system that results in routine dismissal of workers affected by silicosis, black lung, or asbestosis would be unacceptable. Appeal to “trade-offs” under such circumstances could well be a pretext for further oppression and should be guarded against. The State is a source of both intrusion and protection. Some disease burdens and forms of health oppression simply cannot be made visible without State-sponsored surveillance (50). On the one hand, surveillance makes public health interventions to address inequi- ties possible. On the other hand, surveillance may be used to impose additional burdens on those who are already disadvantaged. The only assurance that surveillance will amount to neither privilege nor punishment is atten- tion to the ethical considerations described above: both burdens and benefi ts should be critically weighed and then fairly distributed in a transparent manner in which States are held accountable. P214263_WHO Guidelines on Ethical Issues.indd 23 20/06/17 2:43 PM 24 Guidelines IV. Guidelines As a consequence of the development of ethi- cal norms for the conduct of research during the past few decades, research ethics com- mittees have been established in almost all countries. As surveillance does not fall under the rubric of research, however, there has been no systematic framework for continuous ethical oversight or analysis of the challenges posed by surveillance activities. The following guidelines are premised on the conclusion that ethical scrutiny of public health surveillance is necessary. The guidelines are, necessarily, not prescrip- tive; rather, they seek to highlight trade-offs that must be carefully and routinely weighed. They do not provide concrete defi nitions, measures, precise surveillance parameters or oversight mechanisms that might, on the surface, appear to make decision-making less complex. Concepts like “legitimate public health purpose”, “disproportionate burden”, “community engagement” and “good gov- ernance” cannot be regarded as universal yardsticks for use by decision-makers. Rather, agreement on defi nitions for use in different contexts lies at the very heart of the vexing political and ethical judgements that must be made: grappling with the meaning of con- cepts in specifi c local and national settings represents a fi rst step in ethical engagement. The following guidelines, then, cover (i) the broad responsibility to undertake surveillance and subject it to ethical scrutiny; (ii) the obli- gation to ensure appropriate protection and rights; and (iii) considerations in making deci- sions about how to communicate and share surveillance data. These guidelines represent a starting point for the searching, sustained discussions that public health surveillance demands. Like other international guidelines on research ethics, the ethics of surveillance will require continuous review and revision in the light of experience. Kim Pai factory, Bangkok, June 2015. Source: WHO /Diego Rodriguez P214263_WHO Guidelines on Ethical Issues.indd 24 20/06/17 2:43 PM Guidelines 25 Guideline 1. Countries have an obligation to develop appropriate, feasible, sustainable public health surveillance systems. Surveillance systems should have a clear purpose and a plan for data collection, analysis, use and dissemination based on relevant public health priorities. Member States have an ethical duty to pro- tect population health – not only that of their citizens but that of all people within their borders, including refugees, undocumented workers, and individuals in transit (51) – and to address the disparities that characterize the distribution of morbidity and mortality. The duty to protect population health is the foundation of an affi rmative responsibility to conduct public health surveillance. The exer- cise of that responsibility may be assigned to subnational governmental bodies. Without public health surveillance systems, population health cannot be protected and inequalities cannot be adequately addressed. Inattention to pressing public health needs leads to erosion of trust. Thus, from the per- spective of the common good, the failure of countries and the international community to undertake adequate public health surveil- lance represents a central moral concern. The importance of population health thus imposes upon States an obligation to develop systems that capture data critical to identifying and responding to (outbreaks of) infectious dis- eases, epidemic threats and the toll exacted by injuries and chronic disease, which demand environmental and occupational monitoring or investigation. A commitment to equity and justice can uncover the ways in which pat- terns of morbidity and mortality refl ect and contribute to social inequality. As such com- prehensive systems are beyond the capacity of some countries, the international community, as described in Guideline 6, has the obligation to provide support. Passive systems of surveillance are often suf- fi cient, such as monitoring seasonal outbreaks of infl uenza from incidence and prevalence rates that include neither names nor case veri- fi cation with costly laboratory tests for all indi- viduals with infl uenza-like syndromes. Even in the instance of infl uenza, however, systematic community-based surveillance provides a more accurate depiction of outbreaks. The State might have to establish active surveillance sys- tems, taking proactive steps, for example, to fi nd data: this might require examining clinical records to ensure complete reporting and to confi rm an infl uenza diagnosis. Cancer reg- istries in some countries have included such active surveillance. Surveillance systems often entail the enact- ment of regulations and statutes that impose upon clinicians, health care administrators or laboratories a duty to report to public health registries. To ensure effective surveillance of disease priorities, it is often necessary to man- date the reporting of individually identifi able data, including names and other socio-demo- graphic characteristics. Such intrusion on clini- cal confi dentiality is justifi ed when names are required to ensure the collection of accurate data, which is separate from the need to target interventions. But accurate data and targeted interventions both rest on the moral obligation to prevent harm to others and the common good or to provide the best resources to pop- ulations according to the burden of disease, as in the case of cancer registries. Guidelines 11 and 12 outline the ethical limits to name- based reporting. Public health surveillance activities require investment of societal resources to preserve, protect and promote health. In all countries, but especially in low-resource settings, allo- cating societal resources for public health sur- veillance requires prioritization. This issue is discussed further in Guideline 5. P214263_WHO Guidelines on Ethical Issues.indd 25 20/06/17 2:44 PM 26 Guidelines Once surveillance data are available, Member States have the moral duty to use the data actively to promote better health outcomes. Even when resources limit the capacity of countries to take immediate action on the basis of the fi ndings of public health surveil- lance, the data provide the evidentiary basis for advocacy directed at both the national and global communities, thus potentially empowering the most vulnerable. The pur- suit of equity establishes a warrant for sur- veillance, and the global community should provide the necessary help in moving from collecting and analysing data to action (see Guideline 6). Interior view: a nurse is examining two young children in the dining area of the home; the mother is standing to the left; further to the left is a large stove situated next to a fi replace. Source: The National Library of Medicine P214263_WHO Guidelines on Ethical Issues.indd 26 20/06/17 2:44 PM Guidelines 27 Guideline 2. Countries have an obligation to develop appropriate, effective mechanisms to ensure ethical surveillance. Public health surveillance has inherent benefi ts for the functioning of the public health sys- tem, as well as risks. Countries should have an appropriate, effective mechanism for ensur- ing adherence to ethical standards in both emergency and non-emergency situations. Decisions about changing an established sur- veillance system can pose important ethical challenges. Examples of changes that may require ethical scrutiny include: collecting data elements that reveal stigmatized behaviour; adding new elements of data collection, such as measurements of CD4 counts as part of routine HIV/AIDS surveillance; adopting new uses for existing surveillance data, such as for case management or contact tracing; or using public health surveillance data for commercial or security purposes. In the case of research, review committees monitor adherence to ethics standards. Such an independent, impartial oversight mecha- nism allows for close scrutiny and can ensure that relevant protection is in place. These guidelines do not recommend mechanisms that mirror those that have emerged in the context of research ethics. However, public health surveillance is currently not subject to routine oversight. It is the obligation of coun- tries to decide the most appropriate processes for identifying and addressing the ethical issues that arise in public health surveillance. Box 1 provides some examples of existing mechanisms. Any mechanism or process should ensure ethical implementation of sur- veillance without itself becoming an obstacle to achieving the larger public health goal. (We address the nexus of surveillance and research in Guideline 16.) Such mechanisms of ethical oversight should effectively identify the risks and ben- efi ts of surveillance and suggest measures to enhance the benefi ts, minimize the risks and ensure appropriate weighing of the com- mon good, equity, and respect for persons. Oversight should be continuous, and any substantial changes proposed to the surveil- lance system should be evaluated through an “ethical lens”. Ethical monitoring of surveillance can be facili- tated and enhanced by training public health personnel. Such training can emphasize the importance of integrating ethical analysis early and explicitly when developing and imple- menting a surveillance system. While the establishment of an indepen- dent, impartial ethics oversight mechanism is warranted, concrete implementation will depend on the social, political, legal, and cultural context in which surveillance is con- ducted (52). Research usually entails discrete projects with time-limited horizons, whereas surveillance usually involves continuous monitoring as opposed to a one-time review. The most appropriate mechanism for ethical scrutiny should be chosen in a transparent, accountable fashion. (See guidelines 2 and 5 and the discussion of good governance in section III.) P214263_WHO Guidelines on Ethical Issues.indd 27 20/06/17 2:45 PM 28 Guidelines Box 1. Examples of oversight mechanisms Public Health Ontario (Canada) In 2012, Public Health Ontario published “A framework for the conduct of public health initiatives”. It applies an integrated approach for ethics review, in which all evidence-generating initiatives undergo ethi- cal scrutiny proportionate to the level of risk. Its Ethics Review Board plays a vital role in helping to ensure that research and other initiatives conducted by Public Health Ontario are carried out in a manner that is consistent with the second edition of the Federal “Tri-council policy statement on ethical conduct for research involving humans and other relevant regulations, policies and guidelines”. The Ethics Review Board addresses research, evaluation, surveillance, and quality improvement projects that involve human partici- pants, their data, or their biological materials. Membership of the Board complies with the provisions of the Federal policy statement with regard to expert representation and composition, with members selected from Public Health Ontario and public health units and academic institutions in Ontario. They have expertise in various public health disciplines and in methodology, law, and ethics; the members also include community representatives. (Source: https://www.publichealthontario.ca/en/About/Pages/Ethics-Review-Board.aspx) Centers for Disease Control and Prevention, Public Health Ethics Unit (USA) The Centers for Disease Control and Prevention established the Public Health Ethics Unit in the offi ce of the Associate Director for Science, which collaborates with the Public Health Ethics Committee. It provides support throughout the institution; its aims are to “integrate the tools of ethical analysis into day-to-day operations”. It provides training, fosters and sustains a culture of ethical analysis, and provides guidance for and support in ethics consultations. (Source: https://www.cdc.gov/od/science/integrity/phethics/) National Health Service clinical governance committee (United Kingdom) The National Health Service in the United Kingdom distinguishes between research and non-research activities. Individuals involved in audits, programme evaluation, or public health surveillance are directed to seek advice from the clinical governance offi ce of their local National Health Service organiza- tion. (Source: http://www.nhs24.com/aboutus/nhs24board/boardmeetingsandcommittees/committees/ clinicalgovernancecommitttee/) Public Health Ethics Consultation Service, WHO The Global Health Ethics Unit at WHO created a new mechanism in 2015 to help colleagues working in public health to address ethical issues. Like those of the Ethics Review Board of Public Health Ontario and the Public Health Unit at the Centers for Disease Control and Prevention, the mandate of the Public Health Ethics Consultation Service extends beyond surveillance. Programmes and initiatives are not required to be reviewed by this service: WHO staff solicit advice as needed in order to maximize fl exibility and ensure that ethical consultation is not viewed as a bureaucratic hurdle. Its advice is informal and non-binding. The group is made up of WHO staff, who receive continuing training in public health ethics and seek advice from the global network of WHO Collaborating Centres for Bioethics. (Source: http://www.who.int/ethics/en/) P214263_WHO Guidelines on Ethical Issues.indd 28 20/06/17 2:45 PM Guidelines 29 Guideline 3. Surveillance data should be collected only for a legitimate public health purpose. Governments and others involved in public health surveillance should collect only infor- mation that is relevant for legitimate public health purposes, such as to protect, enable or enhance public well-being, reduce morbid- ity and mortality, increase access to the health system and services and reduce health dispari- ties and thereby inequities. All further discus- sions of public health surveillance in these guidelines is based on the assumption that it is undertaken exclusively for a legitimate public health purpose. Literature on good governance usually con- siders legitimate measures to be those that are publicly defensible, morally justifi ed and/ or socially acceptable in pursuit of a common good. (53, 54) Any collection of personally identifi able information that does not meet these conditions would be ethically problem- atic. A legitimate public health purpose is required not only for the collection of data but also for the further use of data already in hand. Data collected for clinical purposes (for exam- ple to diagnose infectious disease, to moni- tor microbial resistance, to monitor NCDs like diabetes or to track behaviour associated with coronary heart disease or obesity) can be used for legitimate public health surveillance purposes, provided that such use meets the criteria bar set in guidelines 1, 3, 4 and 7–14 of this document. Such repurposing requires adequate protection of data security and con- fi dentiality (Guideline 10). Children`s Environmental Health in India. Source: WHO /Diego Rodriguez P214263_WHO Guidelines on Ethical Issues.indd 29 20/06/17 2:45 PM 30 Guidelines Guideline 4. Countries have an obligation to ensure that the data collected are of suffi cient quality, including being timely, reliable and valid, to achieve public health goals. Data should meet the most exacting yet reasonable standards with regard to com- pleteness, uniqueness, timeliness, validity, accuracy and consistency for the purpose and the resources available to fulfi l that purpose. Where relevant, this requirement extends to external quality assurance of laboratory data. The quality of data is a precondition of their ethical use. Determining the adequacy of data, however, depends, in part, on whether they are to be used to intervene at the level of the individual (e.g. contact tracing) or the population (e.g. estimating the incidence and prevalence of a disease or exposure). Their adequacy will also depend on whether a disease is infectious, noncommunicable or environmental, and whether the condition is chronic or acute. How data quality is assured from a technical perspective will depend on the priority, the context and the type of sur- veillance. While some countries and institu- tions explicitly stress the accuracy or reliability of data (55), others value rapid collection of useful data over complete accuracy. Countries have obligations to ensure suf- fi cient numbers of trained staff to generate and competently analyse surveillance data and promote quality. The quality of surveil- lance data can be improved not only by formal technical evaluation but also by regular audit and benchmarking against national and inter- national norms (56). Countries have an obli- gation to educate people who contribute to surveillance about its goals and to explain why surveillance is conducted, what risks might arise, how those risks can be minimized and any appropriate legal and ethical obligations. Individual health care workers, professional bodies, and agencies (like hospitals and labo- ratories), in turn, have a professional obliga- tion to support and contribute to maintaining the integrity of surveillance activities and to ensure that data of the best possible quality are obtained. Counterintuitively, data quality may be com- promised by widely used performance-based funding mechanisms. Too great an emphasis on achieving targets, linked to funding, can undermine the integrity of surveillance. For example, countries may be pressured to pro- duce data to secure resources, and staff may have to choose between providing either the data desired by funders or the correct data and risk losing their jobs. Realistic target-set- ting at international and national levels and broader international support for surveillance (Guideline 6) are possible solutions to coun- teract the scramble for funding that produces unreliable data. P214263_WHO Guidelines on Ethical Issues.indd 30 20/06/17 2:45 PM Guidelines 31 Guideline 5. Planning for public health surveillance should be guided by transparent governmental priority-setting. Public health surveillance involves the invest- ment of resources that could be allocated to meet other goals, such as clinical care or pre- vention (57). Furthermore, within the resources available for public health surveillance, priorities must be set. Given competing goods, the allocation of scarce resources must inevita- bly engage questions of equity and effi ciency. As no absolute standard can guide such deter- minations, it is critical that decision-making be transparent, fair and open to revision (58). Governments are accountable for how priori- ties are set. Transparency is important because it fosters trust and creates conditions for citi- zens to advance the common good individually and collectively (59). Transparency is essential with respect to: (i) the aims and duration of any public health surveil- lance activity, (ii) the rationale for such activity relative to explicit health or health care system goals, (iii) the intended benefi ts and potential burdens to citizens and other actors of public health surveillance, (iv) the scope and methods to be used in collecting data, (v) the intended uses of data and by whom, (vi) the mechanism by which use of data will be monitored, (vii) the mechanism by which subsequent use of data would be overseen at community level and (viii) the recourse that citizens or other actors may have if public health surveillance fails to meet legal and/or ethical standards. Surveillance data should be publicly reported (see Guideline 13) to the extent that they will increase public trust, serve the aim of promoting and protect- ing public health nationally and internation- ally and will not unduly harm any identifi able group or exacerbate inequity (54, 58). Citizens should have access to mechanisms to express their concerns and priorities with regard to surveillance. For example, commu- nities may express concern about a potential cluster of birth defects or cancers that necessi- tates not only targeted epidemiological studies but also the creation of surveillance systems. Priorities should not be set solely by experts nor by those with access to health offi cials and policy-makers, neglecting populations with less opportunity to voice their concerns. Pandemic containment exercise (simulation), conducted by the Ministry of Indonesia with the support of WHO Indonesia. Source: WHO / SEARO /Nursila Dewi P214263_WHO Guidelines on Ethical Issues.indd 31 20/06/17 2:45 PM 32 Guidelines Guideline 6. The global community has an obligation to support countries that lack adequate resources to undertake surveillance. Some countries may be unable to establish and maintain public health surveillance of suf- fi cient quality, even for high-priority targets that could greatly reduce health inequalities and improve population health, because of severe resource constraints. Equity provides the ethical foundations for claims to interna- tional support. The global community – inter- national health organizations, NGOs, major foundations, countries with a global leader- ship role – has an ethical responsibility to work collaboratively with these countries to support public health surveillance and subsequent interventions. The aim of this requirement of global justice is to reduce health inequalities among countries and improve global health. For example, preventing and limiting the global spread of disease was a key rationale for the obligations under the IHR. Given that outbreaks and risk factors do not recognize borders, the global community also has an interest in having sustainable surveillance sys- tems, even in countries that do not have the means to establish and maintain them (20). Likewise, effectively addressing NCDs and environmental threats requires international support for surveillance (60, 61). Agencies with a strong capacity for surveillance should regularly update technical guidelines for best practices. The international community should help to ensure that both technical and ethical training is widely available. Surveillance may require support not only for technical capacity, however, but also for systematic, formal ethical evaluation and improvement, as demonstrated by global support for training in research ethics. Thus, international organizations also have an obligation to facilitate and encourage coun- tries to practise good governance by meeting their ethical and legal responsibilities. When countries fail to protect the fundamental rights or interests of individuals or populations in public health surveillance, international sup- port should be contingent on their rectifying such violations and wrongdoings. An obligation to support does not give the global community license to ignore the pri- orities of countries that require support or resources. International humanitarian orga- nizations have expressed deep concern that surveillance is too often driven by the secu- rity needs of high-income countries, creating ambiguities about who the chief benefi ciaries of surveillance are (3). When a country’s deci- sions have been made in a participatory, trans- parent manner, the global community has an obligation to meet local surveillance aspirations that exceed or even confl ict with the priorities set by international donors (62). For example, malnutrition may be a priority for surveillance in a country with limited resources, whereas international donors may view that concern as of lower priority than an infectious disease outbreak. Genuine partnerships may require reform of global health governance, shifting the priority from securitization, politics, and trade to “universal health values” (63). Too often, data are collected locally but ana- lysed at State or country level, with minimal feedback. Both the international community and country offi cials should encourage the analysis and use of surveillance data collected at the local level by the local level. Local analy- sis and use can enhance accountability and the capacity to improve population health. When local analysis is not possible, analyses performed at central or national level should be shared with the local level. P214263_WHO Guidelines on Ethical Issues.indd 32 20/06/17 2:45 PM Guidelines 33 Guideline 7. The values and concerns of communities should be taken into account in planning, implementing and using data from surveillance. Offi cials, agencies, and organizations respon- sible for surveillance should try to engage the population beforehand about the goals, pro- cesses, and potential impacts (both positive and negative) of surveillance activities as a means of demonstrating respect for persons. When this is not possible or is not done, those responsible for surveillance must bear in mind that their work is being done without consid- eration of the concerns of the community; those responsible for surveillance necessarily become stewards not only of the common good but of community interests. Engage- ment is particularly important when a surveil- lance activity disproportionately burdens a specifi c population (e.g. through stigmatiza- tion). Engaging with communities, especially those that have been historically marginalized, and empowering them to participate actively is particularly important. Given that some public health surveillance activities require coordination at local, national and interna- tional levels and involve multiple actors, active inclusion and participation of communities may be useful in building or sustaining trust across levels and implementing activities more effi ciently and effectively. It is often diffi cult to defi ne a community, because geographical area is not the only salient characteristic. Shared traditions and values and a common identity may be impor- tant defi ning factors. Health conditions may also help defi ne a community. The appropriateness of engagement is another subject of debate. Some advocates incorpo- rate community engagement in the design, implementation, monitoring and evaluation of surveillance. Community engagement in the dissemination of results is warranted, par- ticularly when the fi ndings may result in stig- matization or discrimination. For others, a commitment to engagement may be more fl ex- ible. Taking account of community values and concerns requires, at a minimum, that legiti- mate authorities undertake public health sur- veillance in a transparent manner in accordance with the principles of good governance. Active engagement of the community may involve meetings with community leaders, focus group discussions and other forums that provide an opportunity for members to clearly express their values and concerns (see Guideline 5 and the discussion of good governance in section III). Box 2. Community engagement A particularly compelling, fl exible method for engaging communities is democratic deliberation. This is a structured method for decision-making that brings together diverse stakeholders to construct solutions to complex policy questions. Participants engage in discussion and dialogue, communicate their perspectives respectfully, and provide justifi cation for their views in a way that everyone involved can grasp. The goal is to make pressing decisions while considering empirical evidence, communities’ lived experience, and values. The US Bioethics Commission (64) has used the deliberative method as it has grappled with diffi cult issues fraught with tension and has made available a variety of training tools (65). While it is only one means of ensuring citizen involvement and is not appropriate for all situations, it has been a staple not only of local and national but also global decision-making. For example, in June 2016, (66) some 10 000 citizens in 76 countries expressed concern about climate change and recommended legally binding measures, including “reporting of [each nation’s] adaptation and mitigation efforts” to keep global warming below 2 °C. (67) P214263_WHO Guidelines on Ethical Issues.indd 33 20/06/17 2:45 PM 34 Guidelines Guideline 8. Those responsible for surveillance should identify, evaluate, minimize and disclose risks for harm before surveillance is conducted. Monitoring for harm should be continuous, and, when any is identifi ed, appropriate action should be taken to mitigate it. Even when public health surveillance is clearly justifi ed to promote the common good, Mem- ber States and those responsible for conduct- ing surveillance should remain alert to the possibility that harm can be caused to both individuals and communities (Table 2). This does not mean that surveillance should not be conducted. Rather, those conducting surveillance have an obligation to identify potential harm beforehand, to monitor for harm during and after surveillance and to put in place processes to mitigate harm. Without continuous monitoring, mitigation is impos- sible. This is vital, not only because it is wrong to cause unnecessary harm, but also because harm – to both individuals and communi- ties, such as loss of property value or tourism dollars – may also damage public trust in the programme and in public health in general. (See guidelines 5, 12 and 13 and the discus- sion of good governance in section III.) In some instances, countries have provided compensation for the harm that might inevitably accompany surveillance. In the con- text of SARS, Chinese Taipei gave people who were quarantined the equivalent of US$ 147 (68). Basic welfare benefi ts or sick pay for those deprived of work as a result of surveil- lance are other possibilities. The possibility of compensation should not, however, pose a barrier to surveillance (69). There are many different types of harm: eco- nomic, legal, psychological, social (and reputa- tional) and physical. All should be considered in relation to surveillance (70-72). For example, a migrant or a person in another disadvantaged group may be identifi ed as being at higher risk for an infectious disease through surveillance, and this could lead to stigmatization of the group. Relevant information must be handled very carefully: reputations can quickly be dam- aged, with devastating results across a spec- trum that may include not-yet-documented types of harm (73). Various moral values and ethical principles should be weighed and bal- anced against each other and a judgement made about fair distribution of burdens and benefi ts in different surveillance initiatives or systems in a transparent way (see discussions of equity and good governance in section III). When, despite all efforts to mitigate harm, surveillance entails a predictable risk for harm (stigmatization, discrimination, expulsion or violence), additional precautions should be Table 2. Types of harm potentially related to disclosure of public health surveillance data Type of harm Result Physical Public attacks, spouse/partner abuse, domestic violence, delayed or inadequate treatment Legal Arrest, prosecution, death penalty, expulsion Social Discrimination, community discrimination, isolation, inability to access care or exclusion from care, rejection from the community Economic Loss of employment or revenue, loss of health care services, loss of insurance, increased insurance premiums, increased health care costs, limited career options, loss of life resources, forced relocation Psychological/emotional Distress, trauma, stigma P214263_WHO Guidelines on Ethical Issues.indd 34 20/06/17 2:45 PM Guidelines 35 taken to protect the individuals or commu- nities at risk. The risk for serious harm may, in rare circumstances, be so great that sur- veillance might be diffi cult to justify morally. In most cases, however, mitigation strategies can ensure that risks for harm are dealt with adequately. Once harm or potential harm is identifi ed, action must be taken to reduce the risk, or a plan must be in place for reducing, removing or compensating for any harm. As not all harm can be eliminated, the ben- efi ts of surveillance should be proportional to the risk for harm. Protective measures should include the way in which health authori- ties present information or action to the media and the broader public. Sensationalist representations of statistical facts can, for example, result in reputational damage and extend the period of economic recovery for those affected by a health issue, as in the case of countries or communities identifi ed as a source of an infectious outbreak. Processes and measures should be in place to miti- gate some of the fi nancial and other harm- ful consequences of surveillance in order to minimize any negative consequences for a community and to maintain trust. Addition- ally, given their mission to mitigate harm, politically neutral international humanitar- ian organizations must not be hindered in situations such as civil confl ict zones, where international agencies are constrained when it comes to recognizing “opposition parties as operational partners” (3). Notably, public health professionals them- selves sometimes require protection. As champions of the common good, they must be free to report without fear of reprisal. As surveillance offi cials have a responsibility to speak up, they should have protection. This idea is established in the IHR, which protects the confi dentiality of those who report a veri- fi able outbreak or a public health event out- side offi cial channels. Health brigades in Chiapas, Mexico, during the epidemic of H1N1 infl uenza, 2009. Source: WHO /Harold Ruiz P214263_WHO Guidelines on Ethical Issues.indd 35 20/06/17 2:45 PM 36 Guidelines Guideline 9. Surveillance of individuals or groups who are particularly susceptible to disease, harm or injustice is critical and demands careful scrutiny to avoid the imposition of unnecessary additional burdens. Individuals or groups in situations of height- ened vulnerability bear an undue proportion of health problems. Responsible authorities should make special efforts to ensure that these populations are included in surveillance in ways that will empower them. How exactly situations of vulnerability should be defi ned is a subject of dispute in the literature (74). Vulnerability may be diffuse, affecting large communities with limited economic develop- ment, limited access to health care facilities, educational deprivation, occupational risks or wider disadvantages in society. Public health surveillance and health information systems can provide valuable information to aid the development of health programmes and ser- vices to address their health problems and the underlying determinants of health, such as clean water, food security, or gender equality. To promote equity, surveillance should focus on the specifi c problems of these vulnerable communities. People with particular susceptibility to disease, harm or injustice are also at increased risk for further burdens, such as discrimination and stigma, attributable to surveillance activities or fi ndings. For example, refugee groups and undocumented migrants with a higher disease burden may be seen, wrongly, as the cause of disease outbreaks. Similarly, workers with an occupational disease, such as silicosis, who lack access to adequate legal support may be dismissed from work rather than receiving treatment or compensation. Wherever pos- sible, susceptible groups should be identifi ed before surveillance activities begin in order to minimize the risk for harm. In surveillance pro- grammes, there should be constant monitor- ing for (further) harm to those in conditions of particular vulnerability. When harm does occur, a mitigation strategy should be put in place (see Guideline 8). The HIV oral test on a brothel bed in Belém do Pará, Brazil. Source: Laura Murray P214263_WHO Guidelines on Ethical Issues.indd 36 20/06/17 2:45 PM Guidelines 37 Guideline 10. Governments and others who hold surveillance data must ensure that identifi able data are appropriately secured. Responsible data collection and sharing prac- tices should ensure the security of the data collected in order to respect persons and safe- guard the privacy and other interests of the individuals and communities concerned (50). Every effort must be made to secure records to prevent unauthorized disclosure. Security is  different from privacy and confi dential- ity, yet it is an essential component of each. “Security” in this context consists of opera- tional and technological safeguards to protect personal data from unauthorized access or disclosure. Maintaining information security is not fool-proof, as electronic databases can be infi ltrated. Governments and others who hold surveil- lance data must take appropriate techni- cal and organizational steps to protect data against accidental or unauthorized access, destruction, loss, use or disclosure, whether the data are collected and stored in paper or electronic (digital) format. All personnel with access to public health surveillance data should be trained annually in data security pro- cedures and made aware of their professional ethical responsibility to protect the data and the public. The level of security must be appro- priate to the risks and the nature of the data to be protected, taking into account the state of the art and the cost. In particular, sensitive information, which raises the risks of individu- als and communities for stigmatization or dis- crimination, should be subject to specifi c and especially rigorous security safeguards. The imperative to secure data should not be considered a license to refuse to use or share surveillance information effectively for legiti- mate public health purposes. (See guidelines 14–17 on sharing and the discussion in Guide- line 2 on meaningful ethics training.) Staff at the Medical Records Offi ce sort through patient fi les at Karapitayam Hospital, Galle. Source: WHO / SEARO /Gary Hampton P214263_WHO Guidelines on Ethical Issues.indd 37 20/06/17 2:46 PM 38 Guidelines Guideline 11. Under certain circumstances, the collection of names or identifi able data is justifi ed. In some instances, the collection of names or identifi able data is both technically and ethically imperative. Effective surveillance may require the de-duplication of records (that is, avoidance of double-counting, which can lead to overestimates of incidence or prevalence). Names and other unique identifi ers (social security numbers, identity card numbers) may also be essential for longitudinal surveil- lance registers, which require correct linkage of records on the same individual and/or their relatives or contacts over time. Unique identi- fi ers may likewise be required to link data from different sources (for example, registries of tuberculosis and HIV, or birth defects and Zika virus infection). Critically, names and other specifi c identifi ers are required for outbreak investigation or case follow-up and contact tracing (e.g. to identify and offer testing and treatment to the sexual and needle-sharing partners of people with sexually transmitted infections). There has been disagreement over whether unique identifi ers can be used instead of names. Unique identifi ers are expensive to cre- ate and, if constructed in a fashion that allows accurate data linkage, could easily be linked back to names. Some countries experimented with coded reporting for HIV infection before ultimately adopting nominative systems. While such systems were initially the only politically viable solution, they were abandoned when they were found not to meet federal funding standards for reliability and validity. However, technological advances have created new possibilities. Digital data can be scrambled and encrypted into unique identifi ers that are perhaps impossible to trace back to individu- als. Good governance requires that the trade- offs of using names as opposed to unique identifi ers or encryption be the subject of continuing, transparent, public discussion that takes into account surveillance system require- ments, changing technical capacity, risks, and evolving norms with regard to unique identi- fi ers (which may become ubiquitous) and their legitimate use (75). Another important consideration in the col- lection of data is the geographical location of Names and addresses of people with dread diseases were regularly reported in newspapers until the 1960s. Source: New York Times, July 22, 1916. Public Domain. P214263_WHO Guidelines on Ethical Issues.indd 38 20/06/17 2:46 PM Guidelines 39 individuals, which can be an indirect identifi er. It is ethically important to prioritize confi denti- ality during the collection of geolocation data and also for the release or sharing of global positioning system data, which should be geo-masked to minimize risk of disclosure, pre- serving spatial distribution but preventing iden- tifi cation of cluster-exact geo-coordinates (76). When the collection of names or unique identifi ers is considered imperative, this requirement should be made explicit in plan- ning the programme. Not only will countries make different judgements, but the require- ment for names may not be uniform within countries. Personal data may be required only at local level, while anonymized or aggregate data may be suffi cient at higher levels in a country or globally. Drone in clear sky. Robert Lynch. Source: CC0 Public Domain P214263_WHO Guidelines on Ethical Issues.indd 39 20/06/17 2:46 PM 40 Guidelines Guideline 12. Individuals have an obligation to contribute to surveillance when reliable, valid, complete data sets are required and relevant protection is in place. Under these circumstances, informed consent is not ethically required. There is a long history of objection to public health surveillance without informed consent. Nevertheless, informed consent is not the default in public health surveillance. Many coun- tries have enacted laws that require such sys- tems to collect personal data without consent, subject to legislatively prescribed safeguards. All individuals in a population are likely to benefi t from surveillance programmes. Indi- viduals, therefore, have a reciprocal obliga- tion to contribute to surveillance and thereby promote the common good. Even when the potential benefi t to any one individual is small, as the epidemiologist Geoffrey Rose famously pointed out, the benefi t to the community as a whole may be large (77). Population benefi ts provide the moral obliga- tion for individuals to contribute. If it is pos- sible to opt out (and too many people do so), public health might be unacceptably com- promised (78). Seeking informed consent is often not feasible in practice, e.g. from large populations. It may be prohibitively costly and unwarranted when the risks are low (as in some epidemiological research in which CIOMS has allowed waiving of consent). In some cases, however, consent is the norm, such as in routine descriptive health sur- veys. It is the obligation of the public health authorities accountable for surveillance to assess the importance and feasibility of seek- ing informed consent. It is important to clar- ify that, when consent is required, it must be genuinely voluntary. Whether or not consent is sought, informa- tion about the nature and purpose of surveil- lance and about any risk for harm should be publicly accessible (see Guideline 13). Rel- evant protection and adequate governance mechanisms (Guideline 2 and the discussion on good governance in section III), appropri- ate ethics training (guidelines 2 and 6) and data security (Guideline 10) will enhance trust in surveillance systems and ensure protection. P214263_WHO Guidelines on Ethical Issues.indd 40 20/06/17 2:46 PM Guidelines 41 Guideline 13. Results of surveillance must be effectively communicated to relevant target audiences. There is compelling, widely accepted moral justifi cation for dissemination of the results of surveillance to relevant target audiences, although it is not a substitute for ameliora- tive action on the part of those responsible for surveillance. At the local level, relevant target audiences include the community, community offi cials and opinion leaders, health care pro- viders (doctors, nurses, health care workers), policy-makers, health advocates and health volunteers. The relevant target audiences may also include Member States, national and international agencies, and NGOs. Although CIOMS guidelines are focused on research, they stress the importance of communicating results, both positive and negative, to “promote and enhance pub- lic discussion”. Without dissemination, the social value of the work cannot be realized. In the absence of appropriate dissemination, those who collect data, including surveillance data, might rightly be accused of exploiting the individuals and groups whose health data they collect and analyse in the name of the common good. The Nuffi eld Council on Bio- ethics argued that, for dissemination to be considered appropriate, those from whom data are collected should understand the implications of the results for both health care and prevention (35). Surveillance fi ndings should be communicated concisely in a way that is understandable to a lay audience and sensitive to community concerns (see Guideline 7). Communica- tion should not seed panic but alert people to relevant risks in a sensible manner. Mass mailings, toll-free information hotlines, social media, newspapers, seminars, and public meetings are all possible means for conveying surveillance information to the communities from which data were collected and analysed and to the public. In resource-limited set- tings, street theatre, and folk art and other community-based methods can be adopted for the same purpose. Communication should also provide meaningful information for phy- sicians, hospital managers and other relevant target audiences. The communication of knowledge is a double- edged sword: on the one hand, knowledge may clearly empower; on the other, it may lead to injury, stigmatization or discrimination. A decision not to broadly publish data might be justifi ed in exceptional circumstances, when doing so might cause signifi cant harm. Likewise, if the affected population is so small (for example, cases of very rare cancers) that identifi cation of individuals, however inadver- tent, might be inevitable, communication can be limited to preserve privacy (79). Decision-makers must also weigh the harm that could result if affected communities are not informed and thus deprived of knowl- edge and the ability to take action to reduce the risks and the capacity to engage in advo- cacy (see Guideline 13). Those responsible for public health have an affi rmative duty to miti- gate the burdens that communication might impose on individuals or groups that are more susceptible to harm or injustice. There is continuing debate about when, if ever, those responsible for the design and conduct of surveillance are ethically obliged to inform the subjects of surveillance about individual results or diagnosis and then refer them to the appropriate service (80). For example, in the early days of the HIV epidemic, when treatment was not avail- able, blinded seroprevalence studies were considered ethically acceptable. In these population-based surveys, HIV status was P214263_WHO Guidelines on Ethical Issues.indd 41 20/06/17 2:46 PM 42 Guidelines not communicated to the study participants. With advances in HIV diagnosis and manage- ment, however, the ethical consensus shifted (81). Guidelines now recommend that sur- veillance systems report results back to con- senting individuals (80, 82, 83). Guidelines also recommend that, after returning results to individuals, those with positive results be referred for proper clinical evaluation, treat- ment and follow-up at nearby health facili- ties. The guidelines also encourage partner testing (76) and referral for psychosocial support. This example underscores the importance of surveillance systems having an engaged oversight body to deal with such issues and make changes on the basis of new evidence or emerging best practices in other jurisdictions (Guideline 2). Relevant ethical considerations in making a judgement about returning information to individuals include feasibility, the possibility of taking action and the potential benefi t to the individual. Map of parasitic disease epidemic area in China at the National Institute of Parasitic Diseases in Shanghai, China. 16 May 2010. Source: WHO / TDR /Simon Lim P214263_WHO Guidelines on Ethical Issues.indd 42 20/06/17 2:46 PM Guidelines 43 Guideline 14. With appropriate safeguards and justifi cation, those responsible for public health surveillance have an obligation to share data with other national and international public health agencies. For a public health surveillance system to be effective, equitable, and promote the com- mon good, it must be capable of receiving and linking data from public agencies responsible for public health. For example, because of the stringent data security that has surrounded HIV surveillance, there have been situations in which data on HIV status have not been shared with those responsible for tuberculosis surveil- lance, obviating systematic identifi cation of cases with co-infection. Public health work- ers cannot respond appropriately to swiftly changing infectious diseases in real time or take appropriate action in the case of chronic conditions without access to appropriate data. The same is true of occupational exposures. There have been examples in which agencies responsible for tracking occupational diseases have not shared data (despite the absence of a prohibition) with agencies responsible for worker protection and workplace regulation (23). A review of the literature indicated that much of the failure to share information is due to poor planning rather than safety concerns. Programmes have experienced technical dif- fi culties in sharing data, some data requiring conversion (e.g. birth year to age) in order to link databases (84, 85). Public health systems should establish frame- works to enable secure sharing of data (see Guideline 10) with other national and inter- national agencies. Early collaboration to align processes in order to avoid foregoing benefi ts or wasting resources is ethically warranted. Ethical frameworks for sharing should respect persons by ensuring that only the data required to fulfi l a suffi ciently important, legitimate public health purpose are shared, that data are not shared more broadly than necessary, and that data are not subsequently re-shared by other agencies, except under the conditions specifi ed elsewhere in this document, e.g.  in guidelines 16–17. When the protection of different datasets is not equivalent, the more stringent privacy standard should be applied. P214263_WHO Guidelines on Ethical Issues.indd 43 20/06/17 2:47 PM 44 Guidelines Guideline 15. During a public health emergency, it is imperative that all parties involved in surveillance share data in a timely fashion. The collection and sharing of data are essen- tial activities in ordinary public health practice. During emergencies, data-sharing takes on increased importance because of the urgency of the situation, uncertainty in the face of incomplete or changing information, the com- promised response capacity of local health sys- tems and the heightened role of cross-border collaboration. For these reasons, “rapid data sharing is critical during an unfolding health emergency” (86). It not only constitutes good public health practice but is ethically imperative. Ethically appropriate, rapid shar- ing of data can help in identifying etiological factors; predicting disease spread; evaluating existing and novel treatment, symptomatic care and preventive measures; and guiding the deployment of limited resources. As dis- cussed in the WHO guidance on managing ethical issues in infectious disease outbreaks (49), clinical and research data that are crucial for emergency response should also be shared. Data-sharing is also an obligation under the IHR in both health emergencies and infectious disease outbreaks. As part of continuous pre-epidemic prepared- ness, countries should review their laws, poli- cies and practices on data sharing to ensure that they adequately protect the confi den- tiality of personal information and address other relevant ethical questions, such as set- tling disputes about the ownership or control of surveillance data. Efforts should be made to ensure that rapid sharing of surveillance information with immediate implications for protecting public health and advancing the common good should not preclude subse- quent publication in a scientifi c journal (87). Medical student and district surveillance offi cer investigating suspected Ebola cases in Western Region of Sierra Leone. Source: WHO /Stéphane Saporito P214263_WHO Guidelines on Ethical Issues.indd 44 20/06/17 2:47 PM Guidelines 45 Guideline 16. With appropriate justifi cation and safeguards, public health agencies may use or share surveillance data for research purposes. Surveillance data have often served as a foun- dation for important public health research (88-90). For example, cancer registries have been used in longitudinal epidemiological studies on survival and treatment effi cacy. It may be permissible to share surveillance data with researchers undertaking studies that (i) are suffi ciently important for advancement of the common good and (ii) would not be feasible without access to the surveillance data in question. There may sometimes be disagreement about what should be con- sidered “suffi ciently important” research to justify sharing of surveillance data for research purposes. This is a matter that local governments, public health authorities and/ or research ethics committees (as described below) should judge, taking into account the considerations and guidelines set out in this document. Sharing of surveillance data for research pur- poses requires appropriate safeguards, such as ethical oversight (see Guideline 2), anonymiza- tion, and data security. While the kind of ethi- cal review required for conducting research is not appropriate for conducting public health surveillance, surveillance data should be shared only for research projects that have been reviewed and approved by an appropriate research ethics committee or another appro- priate body, consistent with international and local standards on the ethical conduct of research. In making decisions about granting access to surveillance data, ethics committees should consider the potential public health impact of research (Is the research suffi ciently important, or does it have, in the language of CIOMS, “social value”?), the risks to the sub- jects involved, the measures in place to protect privacy, and the importance and feasibility of seeking consent.  Striking the appropriate balance between safeguards and research advancement will sometimes be challenging. One controversial way of sharing sensitive information on drug use has been to delete any information on substance use disorders from individual clinical records released to researchers. Such protec- tion in the name of privacy has become the centre of controversy in the context of a wide- reaching opioid epidemic. One group of critics has argued that this has left researchers “fl y- ing blind” (91). Researchers who have been provided with surveillance data should inform public health authorities about their fi ndings. Before surveil- lance data are shared with researchers, there should be agreement about: appropriate data uses, restrictions on data re-sharing, adequate acknowledgement of the data source in publi- cations, and data destruction conditions at the end of the research phase. P214263_WHO Guidelines on Ethical Issues.indd 45 20/06/17 2:48 PM 46 Guidelines Guideline 17. Personally identifi able surveillance data should not be shared with agencies that are likely to use them to take action against individuals or for uses unrelated to public health. While aggregate public health data may be widely shared with agencies outside the health sector and non-state actors responsible for public welfare, sharing personally identi- fi able data is a fundamentally different mat- ter. Access to such personal information by agencies responsible for national security, law enforcement, or the allocation of social ben- efi ts should usually be allowed only after legal due process. To preserve trust in public health surveillance systems, there should be compel- ling justifi cation for sharing identifi able data for non-public health uses. Inappropriate sharing of surveillance data is especially controversial in countries in which law enforcement or other agencies have been implicated in systematic violations of human rights. In these contexts, collaboration with law enforcement agencies may undermine trust in public health surveillance, creating a disincentive for seeking care or honest report- ing of data. This is a particular concern for individuals or groups in situations of particular vulnerability (92). Further, such unwarranted sharing will potentially infl ict long-term dam- age on public health efforts more broadly. The governance mechanisms recommended in Guideline 2 should ensure that the exceptional conditions, if any, under which identifi able sur- veillance data may be shared are specifi ed and made transparent. Such a review will require determination of whether the threat is of suf- fi cient magnitude to warrant potential damage to the integrity of and trust in public health sur- veillance systems. Sanctions must be in place to prevent inappropriate data-sharing by public health agencies and inappropriate use of data by agencies outside the public health sector. WHO Immunization offi cers visit Quang Binh Province, Viet Nam to monitor the Measles-Rubella Immunization campaign. Source: WHO / WPRO /Emmanuel Eraly P214263_WHO Guidelines on Ethical Issues.indd 46 20/06/17 2:48 PM Guidelines 47 A barcode is placed at the entrance of houses. After being fl ashed with a smartphone, the barcode provides information about whether the house was controlled and declared dengue free or not. Source: WHO/TDR /Catalina Cardenas P214263_WHO Guidelines on Ethical Issues.indd 47 22/06/17 2:40 PM 48 The shifting boundaries of surveillance V. The shifting boundaries of surveillance Various “non-State” actors are involved in public health surveillance, including NGOs, faith-based organizations, professional organizations, research institutions, funding agencies, and supranational agencies like WHO and the European Centre for Disease Prevention and Control. Public surveillance functions may even be outsourced to private companies. This may be a cause of concern, as the data may no longer be owned by and accessible to State agencies. Nevertheless, the vicissitudes of surveillance mean that any set of ethical guidelines must cross boundaries – not only national boundaries but lines that have traditionally separated the public from the private (93). The problem of blurred boundaries has become even more complicated in the era of big data. By “big data”, we refer to both the increased volume of data that can now be col- lected and stored, usually in digital form, and the computational power available to pro- cess it rapidly. The ubiquitous use of personal computers, smartphones, wearable devices, closed-circuit cameras, genetic sequencers, semi-autonomous drones, and other technol- ogies means that we produce a steady stream of digital data. A data-centric technological revolution has generated great enthusiasm about the emerg- ing potential benefi ts of mining electronic health records, genomic data and other biolog- ical materials, social media communications, satellite imagery and other digital datasets to identify emerging disease threats, interrupt foodborne disease outbreaks and improve col- laboration among public health organizations. Drones have been hailed as a “game changer” in disease surveillance. Some have argued that drones could uniquely pinpoint an outbreak by identifying a rapid population exodus from a disease zone (94-96). Others are scepti- cal about “drone utopianism”, arguing that drone surveillance should not be a health pri- ority for countries with limited resources (97). Other new technologies, such as phylogenetic analysis of HIV, hold similar promise and peril, involving both use and failure to use data. Indi- viduals who generate information through per- sonal devices are probably unaware of the range of potential subsequent uses of their data. It is unclear whether the private sector has an obli- gation to share those data with public health or government offi cials. Custodians of such data should be aware of the issues that could arise and be involved in discussions about legitimate data-sharing and the steps that should be taken to monitor risk and prevent harm. There have been mounting calls for addi- tional research and ethical analysis on issues related to big data (98). The place of big data and digital disease detection in the public health surveillance landscape remains undetermined, and additional work should be done on privacy and anonymity, the inte- gration of public and private data sets and issues of data validity and reliability (99). The Deputy Director for Surveillance and Epide- miology at the Bill & Melinda Gates Foun- dation recently sounded an important call: “We need ethicists to be working on some of these problems.” In order to remain proactive rather than reac- tive, addressing these issues must represent the next frontier. While these guidelines are a place to start in addressing issues at the inter- section of surveillance and big data, the chal- lenges of this swiftly changing environment should be subject to continuing analysis and ethical monitoring. This challenge must be taken up by the global community. P214263_WHO Guidelines on Ethical Issues.indd 48 20/06/17 2:48 PM The shifting boundaries of surveillance 49 Sphere and continents with binary code zero – one. Source: CC0 Public Domain P214263_WHO Guidelines on Ethical Issues.indd 49 20/06/17 2:48 PM 50 References References 1. Sustainable Development Goals. 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PLoS Comput Biol 2015;11:e1003904.  P214263_WHO Guidelines on Ethical Issues.indd 55 20/06/17 2:49 PM • What is the ethical obligation to undertake public health surveillance? • What are the risks of conducting disease surveillance? How should such risks be balanced against population level benefi ts? • When and how must relevant communities be engaged in the development of surveillance plans? • How should the confi dentiality of surveillance data be protected? • What are the ethical obligations to share relevant public health surveillance data across public health authorities? With public health researchers? With communities and individuals who have contributed to surveillance systems? • Are there circumstances when data sharing must be strictly prohibited? • What institutional mechanisms should be established to ensure ethical issues are systematically addressed prior to data collection, use, and dissemination? These are core questions that those involved in public health surveillance have grappled with for more than a century. To address these and other pressing concerns an international group of experts has developed the WHO Guidelines on Ethical Issues in Public Health Surveillance. Based on a set of core ethical and policy considerations, these 17 guidelines establish the affi rmative duties to undertake surveillance, share data, and engage communities, while recognizing the limits of surveillance. They will be applied in situations characterized by fundamental cultural, economic, and political variability. The goal, therefore, is to enable critical discussion about legitimate ethical tensions and trade-offs and the appropriate governance and oversight of surveillance. For more information, contact: Global Health Ethics Department of Information, Evidence and Research WHO, Geneva Email: ct_ethics@who.int ISBN 978-92-4-151265-7

书!"#$%& '()*#$+,-./01234 犠犎犗犌犝犐犇犈犔犐犖犈犛犗犖犈犜犎犐犆犃犔犐犛犝犈犛犐犖犘犝犅犔犐犆 犎犈犃犔犜犎犛犝犚犞犈犐犔犔犃犖犆犈 世界卫生组织　２０１７ 建议引文格式：ＷＨＯｇｕｉｄｅｌｉｎｅｓｏｎｅｔｈｉｃａｌｉｓｕｅｓｉｎｐｕｂｌｉｃｈｅａｌｔｈ ｓｕｒｖｅｉｌａｎｃｅ．Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ；２０１７．Ｌｉｃｅｎｓｅ：ＣＢＹ ＮＣＳＡ３．０ＩＧＯ． １ 此翻译版权属于江苏省疾病预防控制中心。 此翻译版本不是由世界卫生组织（WHO）创建的。WHO对翻译的内容或准 确性不负任何责任。根据CC BY-NC-SA 3.0 IGO条例，英文原版 WHO guidelines on ethical issues in public health surveillance. Geneva:World Health Organization; 2017. License: CC BY-NC-SA 3.0 IGO.为具有约束力和权威性的版本。 目录 前言 ４!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! 致谢 ５!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! 　Ⅰ　引言 ７!!!!!!!!!!!!!!!!!!!!!!!!!!! 　Ⅱ　背景 １!!!!!!!!!!!!!!!!!!!!!!!!!!! 公共卫生监测定义 １!!!!!!!!!!!!!!!!!!!!! 监测：伦理、法律和历史 １２!!!!!!!!!!!!!!!!!! 　Ⅲ　制定监测伦理的准则 １４!!!!!!!!!!!!!!!!!!!! 现有指南 １４!!!!!!!!!!!!!!!!!!!!!!!!! 公共卫生伦理 １６!!!!!!!!!!!!!!!!!!!!!!! 　Ⅳ　指南 １８!!!!!!!!!!!!!!!!!!!!!!!!!!! 指南１：各国有义务建立适当、可行和可持续的公共卫生监测系统。监测 系统应根据相关公共卫生的当务之急，为数据收集、分析、使用和传播制定明 确的目标和计划。 指南２：各国有义务建立适当、有效的机制，以确保监测符合伦理。 指南３：监测数据的收集只能用于合法的公共卫生目的。 指南４：各国有义务确保所收集数据质量合格、及时、可靠和有效，以实现 公共卫生目标。 指南５：公共卫生监测规划应以透明的、政府确定的优先事项为指导。 指南６：国际社会有义务支持缺乏足够资源进行监测的国家。 指南７：在规划、执行和使用监测数据时，应考虑社区的价值观和关注点。 指南８：监测负责人应在进行监测之前辨别、评估，尽量减少因披露而造 成伤害的风险。对伤害的监督应当是持续的，一旦发现就应采取适当行动以 减轻伤害。 指南９：对那些特别容易受到疾病、伤害或不公正影响的个人或群体进行 监测极其重要，需要仔细审查，避免给他们增加不必要的额外负担。 ２ 指南１０：各国政府和持有监测数据的其他机构必须确保可识别到个人信 息的数据得到适当的保护。 指南１：在某些情况下，收集姓名或身份识别数据是合理的。 指南１２：在需要可靠、有效、完整的数据集，并且相关保护措施到位时，个 人有义务为监测做出贡献。在这种情况下，伦理上不要求知情同意。 指南１３：必须向相关目标受众有效地传达监测结果。 指南１４：在有适当保障措施和正当理由时，负责公共卫生监测的人员有 义务与其他国家和国际公共卫生机构共享数据。 指南１５：在突发公共卫生事件期间，参与监测的所有各方都必须及时共 享数据。 指南１６：在有适当理由和保障措施的情况下，公共卫生机构可以为了研 究目的使用和共享监测数据。 指南１７：可识别个人身份的监测数据不应与下述机构共享，这些机构可 能利用这些数据采取对个人的行动，或将数据用于与公共卫生无关的用途。 　Ⅴ　监测范围的变化 ３５!!!!!!!!!!!!!!!!!!!!!! 参考文献 ３６!!!!!!!!!!!!!!!!!!!!!!!!!!! ３ 前 言 公共卫生监测是应对暴发和流行疾病的基础，但远远超出传染病的范畴。 它有时被称为公共卫生的雷达，可以帮助绘制疾病分布地图、发现发病模式、查 明病因和采取针对性的干预措施。例如，公共卫生监测对于了解日益增长的非 传染性疾病的全球负担至关重要。通过帮助确定发病率和死亡率的模式和原 因，公共卫生监测还有助于保证获得安全的食物、清洁的水、纯净的空气和健康 的环境。 以符合伦理的方式进行的公共卫生监测，是在人群层面上促进人类幸福的 基础，有助于减少不平等。那些由不公平、不公正导致的，且可以预防的痛苦只 有先被发现，才能得到解决。但监测对参与者来说并非没有风险，有时甚至会 造成伦理困境。这就需要参与监测的双方，监测方要考虑到被监测方的风险， 考虑并平衡有关隐私、自主权、公平性和共同的善的问题，知道在实践中如何去 做很具有挑战性。 我很高兴看到世卫组织将伦理作为公共卫生监测的核心，在这一重要领域 发挥了领导作用。《世界卫生组织关于公共卫生监测伦理问题的指南》是这个 领域的第一个国际准则，填补了一个重要空白。制定本指南的目标是帮助决策 者和从业人员解决公共卫生监测中的伦理问题。１７项伦理指南可帮助到每个 公共卫生参与者：政府机构官员、医疗卫生工作者、非政府组织和私营部门的人 员。非常感谢为出版本指南做出重要贡献的专家们和世卫组织的同事们。 世卫组织有理由断言，以预测伦理挑战和积极寻求减少不必要风险的方式 进行的公共卫生监测，为社会福祉提供了架构。现在应由国际社会和各国应对 这一挑战，在其监测系统中执行本指南。 卫生系统和创新部助理总干事 ＭａｒｉｅＰａｕｌｅＫｉｅｎｙ博士 ４ 致 谢 本指南由世卫组织全球卫生伦理团队编写，由ＡｎｄｒｅａｓＲｅｉｓ领导，由卫生 系统和创新、信息、证据与研究部的ＡｂｈａＳａｘｅｎａ负责协调。 世卫组织特别感谢世卫组织指南编写组共同主席：美国得克萨斯农工大学 公共卫生学院、哥伦比亚大学生物伦理合作中心联合主任ＡｍｙＬ．Ｆａｉｒｃｈｉｌｄ和 伊朗伊斯兰共和国克尔曼医科大学的ＡｌｉＡｋｂａｒＨａｇｈｄｏｓｔ。 ＡｍｙＬ．Ｆａｉｒｃｈｉｌｄ是本指南的首席作家和总编辑。ＡｌｉＡｋｂａｒＨａｇｈｄｏｓｔ 提供了技术文案，并负责确保该指南在监测系统运行方面的准确性。Ａｎｇｕｓ Ｄａｗｓｏｎ和ＬｉｓａＭ．Ｌｅ为制定指导原则和讨论做出了重大贡献。ＣａｌｖｉｎＨｏ ＷａｉＬｏｎ提供了关于法律制度和问题的核心文本。ＪｅｎｉｆｅｒＬ．Ｇｉｂｓｏｎ提供了 有关权责和治理的文本。ＲｏｎａｌｄＢａｙｅｒ在本项目的大部分时间里担任合作中 心全球网络主席，和ＲｏｓＵｐｓｈｕｒ以及ＣａｒｌａＳａｅｎｚ在编辑方面发挥了关键作 用。ＲｏｎａｌｄＢａｙｅｒ，ＭｉｃｈａｅｌＳｅｌｇｅｌｉｄ，以及ＡｎｇｕｓＤａｗｓｏｎ实质性地处理了指南 编写组和外部评审员的评论意见。ＭｉｃｈａｅｌＳｅｌｇｅｌｉｄ，ＡｎｄｒｅａｓＲｅｉｓ，ＡｍｙＦａｉｒｃｈｉｌｄ 和ＲｏｎａｌｄＢａｙｅｒ准备了资助本项工作的赠款提案。 世卫组织非常感谢世卫组织指南编写组的贡献，该小组分享了广博的知 识、提供了原始文本和对本指南的评论意见。所有这些人也是本指南的共同 作者： ＫｏｋｏｕＡｇｏｕｄａｖｉ，多哥卫生部；ＪｉｍｏｈＡｍｚａｔ，尼日利亚索科托州乌斯玛努· 丹佛迪沃大学；ＲｏｎａｌｄＢａｙｅｒ，美国哥伦比亚大学梅尔曼公共卫生学院；Ｐｈｉｌｐｅ Ｃａｌａｉｎ，瑞士无国界医生组织；丛亚丽，中国北京大学健康科学中心；Ａｎｇｕｓ Ｄａｗｓｏｎ，澳大利亚悉尼大学；ＣｌａｉｒｅＧａｙｒｅ，比利时纳穆尔大学；ＪｅｎｉｆｅｒＬ． Ｇｉｂｓｏｎ，加拿大多伦多大学生物伦理学联合中心；ＫｅｎｅｔｈＧｏｄｍａｎ，美国迈阿 密大学；ＶｉｊａｙａｐｒａｓａｄＧｏｐｉｃｈａｎｄｒａｎ，印度泰米尔纳德邦公共卫生学院；Ｅｉｎａｒ Ｈｅｌｄａｌ，挪威公共卫生研究所；ＣａｌｖｉｎＨｏＷａｉＬｏｎ，新加坡国立大学生物医学 伦理学中心；ＨｕｓａｉｎＪａｆｒｉ，巴基斯坦阿尔茨海默病委员会；ＬｉｓａＭ．Ｌｅ，美国生 物伦理问题研究总统委员会；ＳｅｒｇｉｏＬｉｔｅｗｋａ，美国迈阿密大学；Ｍｉｎａ ５ Ｍｏｂａｓｈｅｒ，伊朗伊斯兰共和国克尔曼医科大学；ＫｅｙｍａｎｔｈｒｉＭｏｄｌｅｙ，南非斯坦 陵布什Ｓｔｅｌｅｎｂｏｓｃｈ大学；ＢｏａｔｅｎｇＯｋｙｅｒｅ，加纳大学；ＭａｒｉａＣｏｎｓｏｒｃｉａ Ｑｕｉｚｏｎ，菲律宾流行病学和公共卫生干预网培训项目；ＰａｔｈｏｍＳａｗａｎｐａｎｙａｌｅｒｔ， 泰国食品药品监督管理局；ＭｉｃｈａｅｌＳｅｌｇｅｌｉｄ，澳大利亚莫纳什大学；Ｒｏｓ Ｕｐｓｈｕｒ，加拿大多伦多大学；ＥｆｙＶａｙｅｎａ，瑞士苏黎世大学。 十分感谢世卫组织生物伦理合作中心的全球网络及其成员。 世卫组织感谢各观察员提供的支持：ＥｈｓａｎＳ．Ｇｏｓｈｋｉ，伊朗伊斯兰共和国 德黑兰大学；ＫａｔｈｅｒｉｎｅＬｉｔｌｅｒ，英国惠康信托；ＤｅｂｒａＭｏｓｕｒｅ，美国疾病预防和 控制中心；ＰａｔｒｉｃｉａＳｗｅｎｅｙ，美国疾病预防和控制中心；ＨａｎｓＶａｎＤｅｌｄｅｎ，荷兰 乌得勒支大学医疗中心。 非常感谢两名顾问的支持和贡献：ＣａｒｌＨ．Ｃｏｌｅｍａｎ，美国西顿霍尔大学法 学院；ＭｉｃｈｅｌｅＬｏｉ，瑞士联邦理工学院。 本指南得益于一个文献综述小组的工作，该小组成员包括：Ｃｏｒｉｎａ Ｋｌｉｎｇｌｅｒ（组长），德国慕尼黑大学；ＤｉｅｇｏＳ．Ｓｉｌｖａ，加拿大西蒙弗雷泽大学； ＤａｎｉｅｌＳｔｒｅｃｈ和ＣｈｒｉｓｔｏｐｈｅｒＳｃｈüｒｍａｎ，德国汉诺威医学院；ＭｉｃｈａｅｌＶａｕｇｈｎ， 美国哥伦比亚大学公共卫生学院。 世卫组织全球卫生伦理小组感谢世卫组织内部指导组就指南的制定提供 的宝贵建议：ＩｓａｂｅｌＢｅｒｇｅｒｉ，ＭａｒｉｅＣｈａｒｌｏｔｅＢｏｕｅｓｅａｕ，ＳｏｍｎａｔｈＣｈａｔｅｒｊｉ， ＪｏａｎＨｅｌｎＤｚｅｎｏｗａｇｉｓ，ＳｅｒｇｅｙＲｏｍｕａｌｄｏｖｉｃｈＥｒｅｍｉｎ，ＪｅｓｕｓＭａｒｉａＧａｒｃｉａＣａｌｅｊａ， ＭａｒｇａｒｅｔＯｒｕｎｙａＬａｍｕｎｕ，ＡｎａｉｓＬｅｇａｎｄ，ＡｈｍｅｄＭａｎｄｉｌ，ＴｉｍＮｇｕｙｅｎ，ＢｒｕｃｅＪａｙ Ｐｌｏｔｋｉｎ，ＭａｎｊｕＲａｎｉ，ＬｅａｎｅＭａｒｇａｒｅｔＲｉｌｅｙ，ＰａｓｃａｌＲｉｎｇｗａｌｄ，ＣａｒｌａＳａｅｎｚＢｒｅｓｃｉａｎｉ， ＮａｈｏｋｏＳｈｉｎｄｏ，ＭａｔｅｏＺｉｇｎｏｌ，ＲｏｎａｌｄＪｏｈｎｓｏｎ，ＶａｓｅＭｏｒｔｈｙ，ＭａｈｎａｚＶａｈｅｄｉ， ＡｍｉｎＶａｋｉｌ，ＪｉｈａｎｅＴａｗｉｌａｈ． 本指南还受益于一个外部审查小组的工作，该小组成员包括：Ｌａｒｙ Ｇｏｓｔｉｎ，美国乔治城法律中心；ＰｈｉｌｐＺｕｃｓ，ＧａｅｔａｎＧｕｙｏｄｏ，ＭａｒｉｅｋｅＶａｎＤｅｒ Ｗｅｒｆ，瑞士欧洲疾病预防和控制中心；向倪娟，中国疾病预防控制中心公共卫生 应急中心；ＭａｒｔｙｎＫｉｒｋ，澳大利亚国立大学医学、生物学和环境学院；Ｔｈｉｌａｋａ Ｃｈｉｎａｙａ，马来西亚卫生部；ＭｏｈａｍｍｅｄＢｅｎＡｍｍａｒ，曾就职于突尼斯卫生部； ＬｏｒｎａＬｕｃｏ，智利发展Ｄｅｓａｒｏｌｏ大学生物伦理学研究所；ＰｒｅｔＤｈｉｌｏｎ和 ＳｈｉｆａｌｉｋａＧｏｅｎｋａ，印度公共卫生基金会。 特别感谢为本指南做出贡献的全球卫生伦理小组的前实习生们：Ｎｉｃｈｏｌａｓ ６ Ａａｇａｒｄ，ＳａｒａＢｉｒｃｈＡｒｅｓ，ＨａｎａｈＣｏａｋｌｅｙ，ＣｈｒｉｓｔｉｎｅＦｉｓｈｅｒ，ＡｎｔｏｎｉａＦｉｔｚｅｋ， ＴｈｅｒｅｓａＦｕｃｈｓ，ＳａｎｄｒｉｎｅＧｅｈｒｉｇｅｒ，ＣｈｒｉｓｔｉｎａＨｅｉｎｉｃｋｅ，ＳｏｐｈｉｅＨｅｒｍａｎ，Ｋａｔａｌｉｎ Ｈｅｔｚｅｌｔ，ＦｅｌｉｃｔａｓＨｏｌｚｅｒ，ＰａｔｒｉｋＨｕｍｍｅｌ，ＨｅｌｎｅＭａｒｅＪａｃｍｏｎ，Ｅｕｚｅｂｉｕｓｚ Ｊａｍｒｏｚｉｋ，ＳｅｌｎａＫｎｉｇｈｔ，ＰａｔＭｃＣｏｎｖｉｌｅ，ＳａｒａｈＭｃＮｅｉｌ，ＪａｎＮｉｅｋｅ，Ｊｕｌｉａ Ｐｅｍｂｅｒｔｏｎ，ＭａｎｓｉＳｈａｈｉｄ，ＡｌｅｘａｎｄｅｒＳｈｉｖａｒｅｖ，ＭｉｃｈａｅｌＶａｕｇｈｎ． 世卫组织非常感谢得克萨斯农工大学公共卫生学院的ＰｈｕｏｎｇＢａｃｈ Ｈｕｙｎｈ为本指南设计了封面。 世卫组织还要特别感谢以下组织的慷慨支持：瑞士布罗彻基金；澳大利亚 蒙纳士—华威两校联盟种子基金计划“公共卫生安全伦理”项目；英国惠康信 托；美国迈阿密大学生物伦理与健康政策研究所。 Ⅰ　引　言 自１９世纪末以来，疾病监测一直是一项基本的公共卫生活动（表１１），它 是在人群层面上促进人类福祉行动的基础。公共卫生监测是应对疫情暴发和 流行的基础，但远远超出传染病的范畴［１］。公共卫生监测有助于减少不平等， 那些由不平等、不公正导致的，且可以预防的痛苦只有先被发现，才能得到解 决。公共卫生监测对于了解非传染性疾病导致的日益增加的全球负担至关重 要。通过帮助确定发病率和死亡率的模式和原因，公共卫生监测有助于确保获 得安全的食物、清洁的水、纯净的空气和健康的环境。持续的环境监测不仅可 以发现问题，还可以发出预警。职业病监测可以识别工作场所的暴露情况，并 促使监管。监测可以通过提供有关健康及其决定因素的信息，帮助建立负责任 的机构，为制定和评价公共卫生政策提供依据。例如，监测将是实现联合国可 持续发展目标的核心。应用监测结果有助于促进政策选择。因此，如果能及 时、适当地与民众和决策者分享监测结果，获取的监测信息就可以成为宣传 工具。 然而，监测有时会引发激烈的争议。公共卫生监测不仅可能限制隐私，还 可能限制公民其他自由。例如，在疾病流行期间，监测可能会引发强制性检疫、 隔离或财产扣押［２］。当监测涉及基于实名的报告，并在一定程度上可以让民众 获知，就会引发民众对侵犯隐私、歧视和污名化的深切担忧。当暴民式的反应 取代关心、同情和有效的法治时，基于实名的报告就会严重伤害个人及其财产。 ７ 民众认为公共卫生系统不能保护实名的安全或者会以敏感方式发布汇总数据 和相关信息，因此担忧更加严重（“信息”在本指南中简称为“数据”，因为记录包 含的信息在类型和范围上各不相同）。在一些国家，艾滋病病毒／艾滋病（ＨＩＶ／ ＡＩＤＳ）的流行引发了根据姓名追踪病毒携带者的争议，然而即使能保证具体个 人信息的安全性，当危险行为和受影响人群的细节被公开时，像同性恋性工作 者和注射吸毒者这样的人群也会遭受歧视和污名化等社会伤害。由于这些担 忧，ＨＩＶ／ＡＩＤＳ的流行在国家和国际层面都推动了伦理和监管指南的编写，用 于规划、收集和使用个人数据和综合数据。 表１１　公共卫生监测的纬度 范　围 传染性疾病非传染性疾病 环境因素危险因素和风险指标健康系统人口统计变量 健康相关事件 （如食品和药物安全，疫苗反应） 目　标 流行病的早期发现和预警 趋势与空间分析风险监测生成假设卫生系统绩效监测控制措施评价政策分析 数据收集工具 登记案例报告重复调查生物银行 二次利用数据源 以人群为基础的普查或哨点监测 社交媒体 分析类型 发病率和患病率的估计 发病率和患病率的测量 趋势评估 空间分布评价 数据挖掘 用　途 政策变化 结构性干预 病例或流行病检测 检验假设 实施研究 质量保证 ８ 　　由于担心“不能数的东西不算数”，未能实施公共卫生监测常常引发政治和 伦理争议。例如，环境和职业健康倡导者早就提出了这一担心。即使对于至关 重要的事件，监测仍然存在巨大差距。２０１４—２０１６年埃博拉疫情危机凸显了对 疾病的发生和传播缺乏监测能力会带来的潜在的破坏性后果。监测数据的缺 乏严重阻碍了有效的公共卫生或临床反应。埃博拉疫情只是一个引人注目的 例子，说明了系统性监测不足的代价，以及国际社会对关键性监测支持的重要 性。事实上还有许多其他职业性和环境性暴露，如哮喘、矽肺和其他暴露于砷 或铅的有关疾病，无论是在高收入还是低收入国家都没有被统计。一些评论员 认为，只有当公共卫生危机成为“国际和平与安全的威胁”时，监测才会成为高 收入国家的优先事项［３］。但是，即便监测成为优先事项，如何将分散的、无联系 的或整合过的数据集有效地用于公共卫生目的，仍然是个难题。 当污名、歧视或长期不平等的风险很高时，监测往往在公众不知情或不关 心的情况下进行，这就不可避免地涉及价值观冲突，以及关于如何在不伤害个 人或群体的情况下推进公共卫生目标的判断。因此，监测资源的优先权和分配 不仅需要在社会内部，而且需要在全球范围内进行公开辩论。 目前已经有了具有里程碑意义的关于研究的伦理国际指南，比如流行病学 研究，以及监测特定疾病和／或在特定国家使用的具体伦理指南，但还没有通用 的国际伦理准则来指导公共卫生监测。这些监测涵盖传染性疾病、非传染性疾 病（ＮＣＤｓ）、疾病暴发、环境和职业暴露，甚至是国家边界。国际医学科学组织 理事会（ＣＩＯＭＳ）、世界医学协会和其他机构已经认识到这一空白［４］。现在至关 重要的是需要一份通用的国际伦理指南，作为判断超越国界的对所有的疾病和 暴露进行公共卫生监测的基准。 鉴于高收入和低收入地区的公共卫生监测不均衡、不完整，以及不同的国 家和不同行政区依据不同的法律体系授权监测，国际指南的碎片化和仅针对某 些具体疾病的现况就不足为奇了。有很多原因使我们必须以跨越常规界限的 方式处理公共卫生监测中的伦理问题。 公共卫生是在艾滋病、严重急性呼吸综合征（ＳＡＲＳ）、流感、埃博拉出血热、 寨卡病毒感染、肥胖和冠心病等全球健康威胁流行的时代运作的。考虑到许多 疾病是动物源性的，监测将越来越多地涉及监测动物—人的接触。例如，对食 物和动物饲料中的病原体监测必须与对人类中同样病原体的监测联系起来。 如今人们从社交媒体或手机的地理空间移动信息获取数据，其来源是以前 ９ 无法想象的，现在的监测正是在收集和分享数据的能力取得重大进展的情况下 进行的。识别疾病的能力同样也实现了技术飞跃：仅需一个样本，就可以通过 基因分析快速识别病原体或病原菌株。与此同时，社群内部和国际社会内部的 不平等现象更加明显。在利用技术变革的能力方面，不同国家和地区间的差距 越来越大。一些国家的国内冲突不可避免地引发了健康危机，危机局势反过来 又加剧了不平等，并对冲突地区的卫生监督和干预造成了更多障碍［３］，这引起 了联合国各机构和人道主义组织的注意。 这一引人注目的流行病学、社会、经济、政治和技术的全球现状，迫切需要 填补空白的国际指南，明确处理公共卫生监测的伦理问题。这就是公共卫生监 测伦理国际指南的目的。本指南由一个国际专家组编写，其成员包括监测、流 行病学研究、生物伦理、公共卫生伦理和人权方面的专家。本指南的作者们来 自一些国际上主要的研究机构以及一些非政府组织（ＮＧＯｓ），这些非政府组织 既代表参与监测的团体和人群，也代表了那些对监测的收益和负担都非常感兴 趣的团体和人群。作者们还代表了具有不同政治制度、社会价值和当务之急的 南北方国家。 本指南是与发起该项目的世卫组织生物伦理合作中心全球网络合作编写 的，得到了美国疾病预防和控制中心的技术支持，以确保指南考虑到数据收集、 分析和传播的实际程序和成本，从而能够合理使用。本指南的编写基于对相关 研究进行的系统的文献综述和符合《世卫组织指南制定手册》要求的灰色 文献［５］。 本指南的编写目的是确定主要的伦理注意事项，以指导解决监测中可能出 现的争议，而这本身就是政府的伦理义务。处理具体的伦理问题需要在文化、 价值观、资源、政治传统和体制结构不同的情况下进行，有时对个人权利、社区 共济和／或社会福祉的重要性抱有截然不同的期望。本指南还针对在持续的不 公正和／或一再侵犯人权的情况下出现的挑战给出了应对措施。本指南不能为 公共卫生监测中的所有难题提供具体答案。相反，却对公共卫生伦理的一系列 核心考量，本指南规定了以公开透明方式进行监测、分享数据和社区参与的义 务，同时认识到这一义务所受到的限制。对１７项指南的解读不应相互孤立，也 不应脱离对每一项指南的讨论。所有指南及其讨论部分共同阐述了参与监测 方（包括政府机构官员、参与监测的医疗卫生工作者、非政府组织和私营部门） 在做出决策时应仔细考虑和权衡监测数据的收集、分析、共享、交流和使用 问题。 ０１ 虽然本指南没有规定具体的监督机制，但指出鉴于首要任务是进行监测、 分析数据并根据结果采取行动，因此责任和义务就一定要最终落到可持续的、 实用的监督机制，确保系统地、透明地预测和应对公共卫生监测带来的伦理挑 战。各国应确保这些指南的执行，并定期加以监督。 Ⅱ　背　景 公共卫生监测定义 一些国家对监测的定义很狭隘，另一些国家则相当宽泛。本指南涵盖了对 监测的广泛理解。在最简单的提法中，监测的定义是“持续地观察”［６］或“监测 与行动有关的人类事件”［７］。世卫组织一般将监测定义为“持续、系统地收集、 分析和解释健康相关数据，用于规划、实施和评价公共卫生实践”［８］。健康数据 是指与传染性和非传染性疾病、伤害和健康状况及其相关风险和决定因素有关 的数据。对于传染病暴发，以及表明“可能发生国际疾病传播”的事件，《国际健 康条例》（２０５）将监测定义为“出于公共卫生目的，持续系统地收集、核对和分 析数据，在必要时及时传播公共卫生信息，以供评估和采取公共卫生应对措 施”［９］。 各国对公共卫生监测的理解差别很大。虽然监测通常被描述为系统或连 续的，但并非所有国家、机构或学者都选择公共卫生监测的常规性质，而是强调 数据收集的目的和功能（表１１）。同样，尽管疾病和伤害是监测的主要内容， 但一些监测还包括了重要公共卫生事件［１０］和影响健康的环境条件［１］的决定因 素。此外，出生和死亡等事件的人口动态登记虽然没有被明确描述为公共卫生 监测系统的一部分，但往往被认为也是监测。 虽然国际机构经常赞助、补贴和监督中低收入国家的全国调查，以跟踪风 险因素或健康结果的发展趋势，但通常由国家公共卫生部门负责公共卫生监测 和活动。《国际健康条例》承认来自正式报告渠道以外的监测数据，包括非官方 或非正式来源的，只要这些数据符合效度和信度的标准。 一些组织和专家认为，只有那些事先确定了目的的数据收集，即问题导向 的数据收集才符合公共卫生监测的定义［１２］。澳大利亚卫生部使用了更宽泛的 监测流行病学定义——对有效控制相关疾病的发生和传播的所有方面进行持 续的审查［１３］。一些定义明确排除了病例发现（以及随后的检测和治疗）、公共卫 １ 生调查和流行病学研究、而另一些则认为使用流行病学信息属于监测范畴［１４］。 因此，监测不仅可能包括传染病和持续的数据收集，还有可能包括有针对性的 流行病学研究，危险因素调查，或对由食物、水或环境造成的潜在危险进行广泛 地监测，以及在工作场所或健康机构进行筛查。表１１概述了属于公共卫生 监测范围的活动。 虽然可能有更广泛和更狭隘的定义，但一般对监测的理解是收集数据以促 成公共卫生行动，无论是直接干预、确定优先事项、分配资源还是宣传教育。一 组监测专家指出，了解社区的健康状况是促进支持健康行为、识别和处理异常 健康事件，以及防治疾病与伤害的第一步［１２］。除了将监测与行动联系起来以实 现目标外，几乎所有国家、机构和专家都强调将监测结果传达给“需要了解的 人”的重要性，这些人包括公众、决策者、国家和国际科学界、方案规划人员、公 共卫生部门、医疗机构和出资机构，以便能够进行干预、可持续地促进或宣传。 在公共卫生机构日常获得的数据类型方面，公共卫生实践的方式也在迅速 变化。在某些情况下，数据是手工记录并保存在纸上的；在另一些情况下，它们 是通过复杂的电子系统收集、储存和共享的。正如第Ⅴ部分所讨论的，大数据 时代未来可能在公共卫生监测方面有巨大潜力，得到广泛理解，而且目前已经 出现了令人烦恼的伦理问题。 在一些司法管辖区，监测系统可以迅速与电子健康记录直接连接。无论在 公立的还是私立的健康医疗部门，公共卫生监测数据源与临床实践之间实现了 协同工作［１５］。公共卫生数据可用于通知自动决策支持系统或计算工具以触发 警报。研究进一步表明，移动电话的地理空间数据可以准确地描述和预测个人 的位置移动，从而预测疟疾和Ｈ１Ｎ１流感等疾病的传播［１６１８］。 本指南对公共卫生监测系统的定义宽泛，其基础是世卫组织关于监测的一 般定义：持续、系统地收集、分析、解释和分享健康相关数据，用于宣传和规划、 实施和评估公共卫生实践。然而，即使系统能够运作，也需要进行新的、有针对 性的研究，以应对流行病威胁。此外，公共卫生监测系统不仅依赖于临床实践， 而且还可能为临床实践提供信息，并促进临床实践。 监测：伦理、法律和历史 各国建立了范围和目的不同的监测系统。国际法和条例一直是确保所有 国家至少达到基本水平的公共卫生监测的重要手段。１９６９年，世卫组织成员国 通过了《国际健康条例》，这是对《国际卫生条例》的修订和合并，作为在联系日 ２１ 益紧密的世界中加强卫生安全的准则，于１９７１年生效［１９］。《国际健康条例》规 定，所有成员国都有法律义务建立某些核心公共卫生能力，包括监测和数据收 集，目的是预防、控制或应对疾病的国际传播。 ２０３年ＳＡＲＳ危机的经历使得世界健康大会于２０５年５月２３日通过了 对《国际健康条例》的重大修订［９］。《国际健康条例》最初侧重于不多的几种固 定传染病，修订后的《国际健康条例（２０５）》则允许灵活针对可能造成国际关注 的突发公共卫生事件的任何疾病，规定各国有义务建立监测和应对疾病暴发的 核心能力，以控制疾病和公共卫生事件。然而，截至２０１４年１月，还有４８个 国家未能通报其公共卫生能力或计划，另有８１个国家要求延迟履行他们的义 务［２０］。２０１４年暴发的埃博拉疫情表明，许多国家没有完成《国际健康条例》规 定的义务；只有６４个国家“实现了这些核心能力”，只占接受《国际健康条例》约 束国家的１／３。虽然要求所有国家遵守《国际健康条例》，但在一些国家，有限的 资源和政治不稳定因素会对监测构成障碍，如果没有国际援助，就可能无法克 服这些障碍。 《国际健康条例（２０５）》的局限性在于，它主要为应对国际关注的突发公共 卫生事件提供了一个治理准则，该准则既不是为了建立全面的监测系统，也不 是为了解决监测和实践所造成的伦理问题。国际条例与国家法律和条例一样 是一种重要工具，既规定了实施监测的义务，同时也对监测实践进行了限制。 然而，合法的并不总是合乎伦理的。伦理是严格评价法律、法规和实践，以及解 决监测可能造成的价值冲突的重要工具。 地方和国家的监测系统出现于１９世纪，几乎所有的监测系统都包括医生 的病例报告。这些数据最初主要用于记录社会的进步或苦难［２１］。然而，关于个 人权利和人群健康的最激烈的斗争核心是监测措施，随着人们发现了细菌，并 认识到许多疾病是在人之间传播的，这些措施使得对个人层面的干预成为可 能。基于传染病报告的干预措施有时受到欢迎（例如转诊到诊所、提供食物和 衣物），但有时会引起恐慌（当需要接受强制性疫苗接种或治疗、检疫，以及驱逐 出境时）。官方发病率报告通常受到法律、法规和实践的保护而没有公开披露。 监测也是实施人群健康措施的基础，如牛奶的巴氏杀菌、食品和药品生产的监 管、住房改善和其他解决疾病结构性原因的措施。对这些措施的抵制，大部分 来自独立或股份制企业，往往被归咎为争取个人权利的原因。 因担心病人受到干扰和时间被占用，医生往往会对委托他们报告的义务感 到不快，甚至抵制，或根本无视委托他们报告的义务。但并非所有对发病率和 ３１ 死亡率的监测都要求按实名查到病例。例如，在工业化国家，性传播疾病的报 告往往是通过编码而不是姓名进行的［２１］。虽然追踪接触者需要实名，但大多数 医生在患者提供了性伴侣的姓名并坚持治疗时，都会对编码病例进行匿名。实 名是否必要或是否需要知情同意，往往引发辩论，因为在２０世纪，监测范围扩 大到癌症、糖尿病和中风等非传染性疾病，并扩大到职业暴露、药物使用、交通 事故、伤害、疫苗接种状况和疫苗接种反应等［２］。 在２０世纪，一方面往往是受疾病或健康状况影响的人对监测的必要性提 出了质疑；但另一方面监测又是他们要求的“被关心的权利”［２］。与传染病监测 不同的是，非传染性疾病监测所需资金不足，甚至严重不足，即使在高收入国家 情况也是如此［２３］。遭受有毒物质危害的工人和容易受到环境污染物影响的民 众有时加入发起社会运动，以此获得关注和监测所需的资源；然而，更常见的情 况是，慢性病威胁，特别是对弱势群体的威胁，仍然被忽视。 全球危机会暴露出系统性困难，而这些困难往往没有得到充分解决，例如 一些国家向世卫组织提交的数据仍未统计患有结核病的无证移民［２４２５］。但如 果认为目前唯一的挑战是缺乏监测或报告不足，那就错了。结核病监测数据对 于确定全球抗击艾滋病、结核病和疟疾基金的资助水平至关重要。监测人员有 时发现自己面临着很大的压力，无法达到一些被批评为“不现实”的目标，他们 必须在展示“好”结果还是失去工作之间做出选择，在某些情况下，这就对数据 质量产生了不利的影响［２６２７］。 本指南所依据的理解是：监测是公共卫生实践的基础，不能依靠危机或民 众抗议来证明追踪疾病的目的是公共卫生。虽然本指南呼吁行动起来，但并不 是呼吁无约束行动。相反，只有以预测伦理挑战，主动寻求减少不必要风险的 方式进行的公共卫生监测才能为社会福祉提供架构。 Ⅲ　制定监测伦理的准则 现有指南 有关公共卫生监测实践中伦理问题的学术文献有限，主要集中于数据收 集、数据的实际存储、使用、共享以及数据的传播方面。然而，学术文献［２８］不能 替代国家的推荐超越了现有的、只针对特定疾病的指南［２９］。 ４１ 在第二次世界大战后的几十年间，国家机构和各国都出台了一些指导涉及 人的研究的伦理原则、指南和法律。针对被迫成为临床研究对象的个人受到的 严重伤害，新的伦理准则一致优先个人自决，并强调知情同意对研究的重要性， 同时承认在复杂的情况下，在保护人类研究对象与研究的社会效益间不容易取 得平衡。在临床伦理学实践中，自主选择权极其重要，代表着道德世界观的根本 转变［３０３］。 在１９１年的《流行病学研究伦理审查国际准则》中，国际医学科学组织委 员会（ＣＩＯＭＳ）承认现有的以“病人和个体”为对象的指南不适用于涉及“群体” 的研究。经过长时间的讨论ＣＩＯＭＳ达成了共识：强调了《纽伦堡法典》中首先 提出的研究伦理原则的重要性，但承认在流行病学背景下应用该原则需要灵活 性［３４］，并形成一个惯例，即伦理委员会可以在流行病学研究造成的风险“不超过 最低限度”，且获取知情同意会使研究“不切实际”的情况下，放弃知情同意的 要求［３４］。 虽然公共卫生监测可能与流行病学研究使用相同的方法论，但它并不是简 单的另一种形式的研究。在监测中社区是关注的对象。１９１年ＣＩＯＭＳ确认 监测是公共卫生的责任之一，紧急疫情暴发情况下的监测明确要求免除伦理审 查和监督。在极端情况下，监测不能“等待伦理审查委员会的正式批准”［３４］。然 而，紧急情况只占监测活动的一小部分。 直到２０９年修订，ＣＩＯＭＳ准则才明确支持持续的基于病例的公共卫生监 测无须知情同意。修订报告指出，“要求所有从业人员向公共卫生监测登记系 统提交相关数据的普遍做法得到如下几个考虑的支持：有关全人群综合信息的 重要性；科学性要求包括所有案例以避免无法觉察的选择偏倚；普遍的伦理原 则要求在人群中平等分配负担和利益”［３５］。 这一立场与英国Ｎｕｆｉｅｌｄ生物伦理理事会的立场相呼应。２０７年， Ｎｕｆｉｅｌｄ生物伦理理事会警告不要允许个人选择不报告，称“我们注意到几个例 子，要求知情同意已经产生或可能产生严重的消极后果”［３６］。尽管理事会全面 认可未经同意的强制性的实名病例报告，但也强调必须对监测的界限做出伦理 判断［３６］。 无论是ＣＩＯＭＳ还是Ｎｕｆｉｅｌｄ生物伦理理事会都没有为公共卫生监测提供 更多的伦理指南，也没有解决如何将监测与涉及人的研究区分开来这一棘手问 题。公共卫生的监测和研究在伦理上是否有实质性的差异［４，３７］？它们是否需 ５１ 要不同的一般性指南和监督机制？公共卫生监测是否需要任何形式的正式指 南或持续监督？实际上，在研究和监测，或者研究与其他形式的重要社会调查 （如质量改进、实施研究、口述历史，甚至新闻）之间划清界限一直是一个挑战， 到目前为止仍没有足够明确的解决方案［３８３９］。因此，一个监测专家领导小组强 调，需要“超越研究与实践之间正式的分界线”［２９］。本指南力求做到这一点，不 是通过制定新的定义，而是通过强调公共卫生监测以民众福祉为中心，以及相 应的伦理指导和审查的必要性，建立一种以满足公共卫生需求为责任的伦理模 式，这种伦理模式有别于半个世纪以来一直主导公共卫生研究的伦理模式。 公共卫生伦理 公共卫生伦理学在过去二十年中发展迅速，主要致力于阐明和探讨在寻求 人群健康过程中出现的伦理问题，这导致了对诸如共同的善、公平、共济、互惠 和民众福祉等概念的重视。注重个人的价值观：如自主、隐私、个人权利和自由 不是重要的伦理考虑；而是那些更加“社会的”或“公共的”价值观反映在相关但 并不完全重叠的概念中，这些概念体现了社区的重要性和采取行动的明确义 务。该领域的一些人借鉴公共卫生的社群主义传统［４１］，使用“共济”这个词［４０］； 另一些人则将其描绘为互惠的相互义务［４２］。Ｎｕｆｉｅｌｄ生物伦理理事会试图通 过“管理”的概念来体现政府在公共卫生方面的义务和责任［３６］。 经过认真审查、思考和审议，世卫组织指南编写小组确定，以下伦理考量对 公共卫生监测特别重要，也是本指南的基础： 共同的善：监测被广泛认为是一种公共的善［４３］，它所提供的一些利益不能 再细分为个人的私人利益，因为这些利益本质上是分享的［４１，４］。从根本上说， 监测因其是为了所有人的善而被证明是合理的。如果没有公共卫生机构的充 分监督以及个人和社区的参与，监测的共同利益就会受到威胁。有一份关于经 济和道德哲学的复杂文献试图界定并区分“公共的善”“公共产品”和“共同的 善”等术语［４５］。经过慎重考虑，世卫组织指南制定小组采纳了“共同的善”一词， 反映公共产品的概念，这比狭义的经济概念更能广泛地理解公共产品的概念。 公平：公共卫生伦理主要关注公平的概念。众所周知，社会不公平会对健 康产生负面影响［４６］。并非所有的不平等都在人类的控制范围内，或者与道德有 关。道德上有问题的不平等通常被称为不公平。一个公正的或公平的社会将 努力为人类的繁荣提供公平的条件，而健康就是其中的一个核心要素。公平有 时要求最弱势的人们获得看似不成比例的资源，也就是说风险分布的不平等需 ６１ 要额外的资源来平衡。公共卫生监测可以通过确定包括全球社区的弱势人群 的特殊问题，为有针对性的卫生活动提供依据，并确定健康方面不平等差距的 基础，从而进一步追求公平。 尊重人：公共卫生伦理关系到个人的权利、自由和其他利益，以及全体民众 的幸福。一旦有可能，个人应参与对他们有影响的决定。在一些情况下，个人 应该能够自由地为自己做出选择；在另一些情况下，当可能需要对人群进行干 预时，也可以征求个人的意见，并让他们参与决策。但许多人（如幼儿）不能为 自己做出选择，国家有义务保护他们并保障他们的长期健康利益。 开展公共卫生监测本身就可以说是对人的尊重。对人的尊重进一步要求 确保有关个人和群体的数据得到保护，并尽可能将危害的风险降到最低。最 后，通过保护或改进措施，监测进一步体现了对人的尊重。 善政：虽然善政不是一项伦理原则，而是一种政治愿望，但它仍受到若干伦 理考虑的制约。为确保系统地、公平地应对公共卫生行动带来的伦理挑战，管 理机制必须是负责任的，并且接受公众监督。虽然为保护共同的善必须凭借现 有的最佳证据，但在面临不确定性情况时，还是不得不做出决定。问责制、透明 性和社区参与是证明促进尊重个人、公平和共同的善的公共政策结构正当的手 段。透明性要求明确传达监测政策和程序，并要求受影响的个人或社区了解与 他们有关的任何决定。透明性还要求公开报告监测结果（以匿名或汇总的形 式）。如果不了解这些结果，就意味着社区没有被赋予职权要求政府采取行动， 或在没有其他选择的情况下保护自己。 以上并不是与监测方案及实践性质有关的仅有的相关伦理考虑，而是参与 本指南制定的人对于在公共卫生监测特定背景下做决定的主要考虑。 尽管在过去几十年里，全球范围的讨论已经就如何最好地界定关于研究的 伦理达成了一致，但关于公共卫生伦理的讨论还没有取得一致。因此，即使在 明确以公共卫生伦理为基础的文件中，用词和着重点仍然存在差异。本指南是 世卫组织最近发起的为疾病控制制定的三项伦理准则之一。在２０１０年第一版 《结核病预防保健和控制伦理指南》［４７］的基础上，《实施遏制结核病战略的伦理 指南》［４８］提出了最关键的挑战——到２０３０年，结核病死亡人数减少９５％； ２０１５—２０３５年期间新增病例数减少９０％。２０１６年的《传染病暴发时处理伦理 问题的指南》［４９］针对２０１４—２０１５年西非暴发的埃博拉出血热，强调必须提供伦 理指导，不仅仅是“对特定病原体进行隔离”，而是“普遍适用于传染病暴发的各 ７１ 种伦理问题”。这三个指南的制定显然具有重要的连续性。例如，所有这些都 强调公平、正义和共同的善（有时表述为“管理”或“互惠”）。所有这些都强调尊 重人的尊严的重要性（有时强调自主权或隐私权）。问责制和善政的重要性都 明确地或含蓄地体现在这三个指南中。根据不同的主题，这三个指南也有相关 的差异。例如，结核病指南涉及疾病耐药性问题，因此强调伤害的原则。关于 传染病暴发的指南关注处于极其弱势状况下的群体，以及传染病暴发可能以何 种方式演变为危机，恐惧和不信任会进一步加剧这种危机，故而更要加强调人 权。鉴于需要在不确定的情况下做出决定，该指南还强调效用、相称性和有 效性。 根据本指南制定委员会估计，上文所概述的，并在随后的指南中重复和扩 大的伦理考虑，对证明监测的正当性至关重要。监测作为一项核心活动，范围 超越了疫情暴发或传染病流行。它们必须适用于可能在根本方面有所不同的 情况。上述指南认识到，对价值的权衡有时是不可避免的。各国的传统和当务 之急有时可能导致相互对抗的价值观和优先事项之间的不同平衡。然而，必须 强调的是，并非所有的权衡在道德上都是可以接受的。某些地方、国家或区域 可能具有严重的不公正或侵犯人权的特点。在这种情况下公共卫生监测不是 为共同的善服务，而是成为侵犯尊重、公平和正义的工具。例如在性工作属于 刑事犯罪的国家，艾滋病病毒监测可能被用于压迫。同样，导致受矽肺、黑肺或 石棉沉滞症影响的工人被例行解雇的职业病监测系统也是不可接受的。在这 种情况下，呼吁“权衡”很可能成为进一步压迫的借口，应加以防范。 国家既是干涉也是保护的来源。如果没有国家支持的监测，一些疾病负担 和健康问题根本就无法显现［５０］。一方面，监测使解决不平等问题的公共卫生干 预措施成为可能；另一方面，监测也可能给那些弱势群体增加额外负担。监测 既不是荣幸也不是惩罚的唯一保证就是关注上述伦理考虑——严格权衡负担 和利益，然后以透明的方式公平分配，各国要在其中承担责任。 Ⅳ　指　南 在过去的几十年，由于制定了关于研究的伦理规范，几乎所有国家都设立 了关于研究的伦理委员会。然而，因为监测不属于研究的范畴，所以并没有针 对监测活动的系统性准则以对其所造成的挑战进行持续的伦理监督或分析。 ８１ 以下指南的前提是，对公共卫生监测进行伦理审查是必要的。 本指南是必要的，而非规定性的，它试图强调必须对权衡进行谨慎地和经 常性地斟酌。指南没有提供具体的定义、措施、确切的监测参数或监督机制，这 表面上似乎可能使决策不那么复杂。“合法的公共卫生目的”“不成比例的负 担”“社区参与”和“善政”等概念不能被视为所有决策者使用的普遍标准。就不 同情况下使用的定义达成一致，是必须做出的令人烦恼的政治和伦理判断的核 心。在特定的地方和国家背景下，努力理解概念的含义是伦理实践的第一步。 本指南包括：①进行监测并接受伦理审查的广泛责任；②确保适当的保护 和权利的义务；③决定如何交流和共享监测数据时的注意事项。本指南是公共 卫生监测所要求的讨论的起点，讨论必须是认真彻底的和持续的。与其他关于 研究的伦理的国际指南一样，监测伦理将需要根据经验不断审查和修订。 指南１：各国有义务建立适当、可行和可持续的公共卫生监测系统。 监测系统应根据相关公共卫生的当务之急，为数据的收集、分析、使 用和传播制定明确的目标和计划。 　　成员国有伦理义务保护全体民众的健康，不仅是本国公民的健康，而且是 本国境内所有人的健康，包括难民、非法劳工和过境人员［５１］，并弥补发病率和死 亡率分布的差距。保护民众健康的义务是履行确定的公共卫生监测责任的基 础。这一责任可分配给国家的各级政府机构去履行。 没有公共卫生监测系统，民众健康就无法得到保护，不平等问题就无法得 到充分解决。忽视紧迫的公共卫生需求会损害信任。从共同的善的角度来看， 各国和国际社会未能进行充分的公共卫生监测是一个主要的伦理问题。因此， 民众健康的重要性迫使各国有义务开发数据收集系统，这对查明和应对传染病 （暴发）、流行病威胁和伤害，以及慢性病造成的损失极其重要，该系统需要环境 和职业监测或调查。保证公平或正义可以揭示发病率和死亡率模式如何反映 和助长社会不平等。由于这种综合的数据收集系统超出了一些国家的能力，如 指南６所述，国际社会有义务提供支持。 虽然被动监测系统往往是足够的，例如从发病率和患病率监测季节性流感 的暴发，这种监测既不包括姓名，也不包括对所有的有流感样症状的个人进行 昂贵的实验室检测以核实病例。然而以流感为例，即使是基于社区系统性的主 动监测也能更准确地描述疫情。国家可能不得不建立积极的监测系统，采取主 ９１ 动行动，比如主动去寻找数据，这可能需要检查临床记录，以确保完整的报告和 确定流感诊断。一些国家的癌症登记系统就包括了这种主动监测。 监测系统往往需要制定法规和规章，加强临床医生、卫生保健管理人员或 实验室向公共卫生登记系统报告的责任。为确保有效监测重点疾病，往往有必 要要求强制报告可识别具体个人的数据，包括姓名和其他社会人口特征。当需 要实名报告以确保收集数据的准确性时，这种对临床上保密性的侵犯便是合理 的。数据与针对性干预的需要是分开的，但准确的数据和有针对性的干预措施 都基于这样的伦理义务，即防止对他人和共同的善的伤害，或根据疾病负担向 民众提供最佳资源，如癌症登记。指南１和指南１２概述了基于实名报告的伦 理限制。 公共卫生监测活动需要投入社会资源，以维护、保护和促进健康。在所有 国家，特别是在资源匮乏的情况下，需要优先为公共卫生监测分配社会资源。 指南５进一步讨论了这个问题。 一旦获得监测数据，成员国就有伦理义务积极地利用这些数据促进更好的 健康结果。即使资源限制了一些国家根据公共卫生监测结果立即采取行动的 能力，这些数据也为针对国家和国际社会的宣传提供了证据基础，从而可能使 最弱势群体获益。追求公平确立了监测的理由，国际社会应提供必要的帮助， 从收集和分析数据转向采取行动（见指南６）。 指南２：各国有义务建立适当、有效的机制，以确保监测符合伦理。 公共卫生监测对公共卫生系统的运作既有内在的好处，也有风险。各国应 建立适当、有效的机制，确保在紧急情况和非紧急情况下都能坚持伦理标准。 改变既定监测系统的决定可能带来重大的伦理挑战。可能需要伦理审查做出 的改变包括：收集那些可能泄露的被污名化行为的数据内容，增加数据收集的 新内容，例如将增加测量ＣＤ４计数作为常规艾滋病监测的一部分；将现有监测 数据用于新用途，例如用于病例管理或接触者追踪，或将公共卫生监测数据用 于商业或安全目的。 就研究而言，审查委员会监督伦理标准的执行情况。这种独立、公正的监 督机制支持仔细地审查，并可以确保相关保护能够到位。本指南不建议借鉴关 于研究的伦理背景下产生的伦理机制。然而，公共卫生监测目前不受例行监 督。各国有义务制订最适当程序，以确定和解决公共卫生监测中出现的伦理 问题。 ０２ 　例１ +56789 安大略公共卫生署（加拿大） ２０１２年，加拿大安大略省公共卫生署公布了“开展公共卫生措施的准 则”。采用了一种综合的伦理审查办法，在这种办法中，所有产生证据的举 措都要接受与其风险程度相称的伦理审查。其伦理审查委员会发挥着至 关重要的作用，帮助确保安大略省公共卫生署开展的研究和其他活动符合 第二版由三个理事会共同起草的联邦《关于涉及人的研究的伦理行为的政 策声明》及其他相关法规、政策和指南。伦理审查委员会负责研究、评价、 监督和质量改进项目，这些项目涉及人类参与者及其数据或生物材料。该 委员会成员符合联邦政策声明中关于专家代表和组成的规定，成员来自安 大略省公共卫生部门和学术机构，他们在各种公共卫生学科以及方法论、 法律和伦理方面具有专门知识，此外成员还包括社区代表。 （来源：ｈｔｐｓ：∥ｗｗｗ．ｐｕｂｌｉｃｈｅａｌｔｈｏｎｔａｒｉｏ．ｃａ／ｅｎ／Ａｂｏｕｔ／Ｐａｇｅｓ／Ｅｔｈｉｃｓ ＲｅｖｉｅｗＢｏａｒｄ．ａｓｐｘ） 美国疾病预防和控制中心公共卫生伦理委员会 美国疾病预防和控制中心在科学副主任办公室设立了公共卫生伦理 办公室，该办公室与公共卫生伦理委员会合作，为整个机构提供支持，旨在 “将伦理分析的工具纳入日常运作”。该办公室提供培训，促进和维持伦理 分析文化，并在伦理咨询中提供指导和支持。 （来源：ｈｔｐｓ：∥ｗｗｗ．ｃｄｃ．ｇｏｖ／ｏｄ／ｓｃｉｅｎｃｅ／ｉｎｔｅｇｒｉｔｙ／ｐｈｅｔｈｉｃｓ／） 英国国家卫生服务临床管理委员会 英国国家卫生服务机构将研究活动和非研究活动做了区分。参与审 计、方案评估或公共卫生监测的个人应直接向当地国家卫生服务组织临床 治理办公室寻求建议。 （来源：ｈｔｐ：∥ｗｗｗ．ｎｈｓ２４．ｃｏｍ／ａｂｏｕｔｕｓ／ｎｈｓ２４ｂｏａｒｄ／ｂｏａｒｄｍｅｔｉｎｇ ｓａｎｄｃｏｍｍｉｔｅｓ／ｃｏｍｍｉｔｅｓ／ｃｌｉｎｉｃａｌｇｏｖｅｒｎａｎｃｅｃｏｍｍｉｔｔｅ／） 世卫组织公共卫生伦理咨询服务处 世卫组织全球卫生伦理办公室于２０１５年建立了一个新机制，帮助从 事公共卫生工作的同事解决伦理问题。与安大略省公共卫生伦理审查委 员会和美国疾病预防和控制中心公共卫生办公室一样，公共卫生伦理咨询 １２ 服务处的职责超出了监测的范围。该处不需要审查项目和举措：世卫组织 工作人员根据需要征求意见，以最大限度地提高灵活性，并确保伦理咨询 不被视为官僚障碍。它的建议是非正式的，不具约束力。该办公室成员由 世卫组织工作人员担任，他们接受公共卫生伦理方面的持续培训，并向世 卫组织生物伦理合作中心全球网络寻求建议。 （来源：ｈｔｐ：∥ｗｗｗ．ｗｈｏ．ｉｎｔ／ｅｔｈｉｃｓ／ｅｎ／） 例１提供了现有伦理督促机制的一些例子。任何机制或程序都应确保以 伦理的方式实施监测，而不能让其本身成为实现更大的公共卫生目标的障碍。 指南１６中讨论了监测和研究的关系。 这种伦理监督机制应有效辨别监测的风险和收益，并提出措施，以增加收 益，将风险降到最低，并确保适当权衡共同的善、公平和对人的尊重。监督应当 是持续的，对监测系统提出的任何实质性修改都应通过“伦理视角”加以评估。 通过培训公共卫生人员，可以促进和加强对监测的伦理监督。这种培训可以 强调在开发监测系统和实施监测活动时尽早地、明确地整合伦理分析的重要性。 建立一个独立、公正的伦理监督机制对于实现监测符合伦理是有保证的， 但具体的执行还取决于进行监测的社会、政治、法律和文化背景［５２］。研究项目 通常受时间限制且互不相关，而监测通常需要持续的伦理监督，而不是一次性 的伦理审查。应以透明、负责任的方式选择最适当的伦理审查机制（见指南２ 和指南５以及第Ⅲ部分中关于善政的讨论）。 指南３：监测数据的收集只能用于合法的公共卫生目的。 参与公共卫生监测的政府和其他部门应只收集与合法公共卫生目的相关 的信息，例如保护，促成或加强公共福祉，降低发病率和死亡率，增加获得公共卫 生服务的机会，缩小卫生差距从而减少不平等。本指南中关于公共卫生监测的所 有进一步讨论都是基于这样的假设——监测完全是为了合法的公共卫生目的。 关于善政的文献通常认为合法措施是那些为追求共同的善而公开辩护，合 乎道德的和／或被社会所接受的措施［５３５４］。任何不符合这些条件的针对个人身 份信息的收集都存在伦理上的问题。合法的公共卫生目的不仅是为了收集数 据，而且是为了进一步使用已有的数据。 为临床目的收集的数据（例如诊断传染病、监测微生物耐药性、监测糖尿病 ２ 等非传染性疾病，或跟踪与冠心病、肥胖有关的行为）可用于合法的公共卫生监 测，但此类使用必须符合本文中指南１、指南３、指南４和指南７～１４规定的标 准。数据的再利用需要充分保证其安全和保密性（指南１０）。 指南４：各国有义务确保所收集数据质量合格、及时、可靠和有效，以 实现公共卫生目标。 　　数据应符合最严格的，但也是合理的标准，应具有完整性、唯一性、及时性、 有效性、准确性，并使目标和为完成目标所用的资源保持一致。在相关情况下， 这一要求延伸到实验室数据的外部质量保证。数据的质量是数据使用符合伦 理的先决条件。然而，确定数据是否充分，在一定程度上取决于这些数据是被 用于个人层面的干预（例如追踪接触者），还是人群层面的干预（例如估计疾病 和暴露的发生率和流行率）。数据的充分性还取决于一种疾病是传染性疾病、 非传染性疾病还是环境性疾病，以及这种疾病是慢性的还是急性的。如何从技 术角度确保数据质量则取决于优先事项、背景条件和监测类型。虽然一些国家 和机构明确强调数据的准确性或可靠性［５］，但另一些国家和机构则认为快速收 集有用的数据价值超过完全准确的数据。 各国有义务确保有足够数量训练有素的工作人员收集监测数据，并且能够 胜任数据分析并提高数据质量的工作。监测数据的质量不仅可以通过正式的 技术评价来提高，还可以通过定期审查和参照国家和国际规范来提高［５６］。各国 有义务使监测人员理解监测的目的，并向他们解释为什么要进行监测、可能产 生哪些风险、如何将这些风险降到最低，以及所有适当的法律和伦理义务。卫 生工作者包括个人、专业团体和机构（如医院和实验室）则反过来有专业义务支 持和促进保持监测活动的完整性，并确保获得尽可能最佳质量的数据。 与正常理解相反，广泛使用的基于绩效的资助机制可能会损害数据质量。 过分强调完成与资金挂钩的目标会破坏监测的完整性。例如，为保护资源各国 可能被迫生成数据，工作人员可能不得不做出选择，是提供资助者所期望的数 据，还是冒着失去工作的风险提供正确的数据。针对这种问题国际和国家一级 要设定切实可行的目标，为监测提供更广泛的国际支持（指南６），以消除因为争 夺资金而产生不可靠数据的情况。 指南５：公共卫生监测规划应以透明的、政府确定的优先事项为指导。 公共卫生监测涉及可用于满足其他目标的资源投资，如临床护理或预 防［５７］。此外，必须根据确定的优先事项来分配公共卫生监测的可用资源。鉴于 ３２ 稀缺资源是竞争品，其分配必然涉及公平和效率问题。由于没有绝对标准能指 导这种决定，关键在于决策必须透明、公平和开放，以便于修订［５８］。各国政府对 如何确定优先事项负有责任。透明度很重要，因为可以促进信任，并为公民个 人和集体推进共同的善创造条件［５９］。 透明度对于以下方面至关重要：①所有公共卫生监测活动的目标和持续时 间；②与明确的健康或卫生保健系统目标有关的此类活动的理由；③对公民和 公共卫生监测其他参与者的预期好处和潜在负担；④收集数据的范围和方法； ⑤数据的预定用途和使用者；⑥监督数据使用情况的机制；⑦应该在社区一 级监督数据的后续使用机制；⑧如果公共卫生监测不符合法律和／或伦理标准， 公民或其他参与者可能采取的补救措施。应公开监测数据（见指南１３），以增进 公众信任，促进和保护国家和国际公共卫生，并且不会过度损害任何可被识别 身份的群体或加剧不平等［５４，５８］。 公民应该能够利用各种机制提出他们在监测方面的关切和优先事项。例 如，社区可能对潜在的出生缺陷或癌症群发表示关注，这不仅需要进行针对性的 流行病学研究，而且需要建立监测系统。优先事项不应只由专家或那些能够接触 到卫生官员和决策者的人来确定，而忽视了较少有机会表达其关切的人群。 指南６：国际社会有义务支持缺乏足够资源进行监测的国家。 由于严重的资源短缺，一些国家可能无法建立和维持足够高质量的公共卫 生监测，即使是对于能够大大减少卫生不平等和改善人群健康的高度优先目 标。“公平”为呼吁国际支持提供了伦理基础。国际社会（国际卫生组织、非政 府组织、主要基金会、具有全球领导作用的国家）对此负有伦理责任，应该与这 些资源短缺国家合作，支持这些国家的公共卫生监测以及后续的干预措施。这 一全球正义的目的是减少各国之间的卫生不平等，改善全球卫生。 例如，预防和限制疾病的全球传播是《国际健康条例》义务的一个关键依 据。鉴于疫情和危险因素不受边界限制，即使在没有能力建立和维持这些系统 的国家建立可持续的监测系统也符合国际社会的利益［２０］。同样，有效应对非传 染性疾病和环境威胁也需要国际社会对监测的支持［６０６１］。具有强大监测能力 的机构应该定期为最佳实践更新技术指南。国际社会还应帮助确保普及技术 和伦理培训。 监测不仅需要技术能力方面的支持，还需要系统的、正式的伦理评价和改 进，全球对关于研究的伦理培训的支持就证明了这一点。因此，国际组织也有 ４２ 义务通过履行其伦理和法律责任，促进和鼓励各国实行善政。当某些国家未能 在公共卫生监测中保护个人或人群的基本权利或利益时，国际组织应视其纠正 侵犯和不法行为的情况提供援助。 援助的义务并不意味着国际社会可以忽视需要援助或资源的国家所面临 的当务之急。国际人道主义组织已经表达了深切的关注——监测往往受高收 入国家的安全需要所驱动，造成监测主要受益者不明的问题［３］。当一个国家以 参与性的和透明的方式做出决定时，国际社会有义务满足当地的监测愿望，即 使这些愿望超过，甚至与国际捐助者确定的优先事项相抵触［６２］。例如，在资源 有限的国家，营养不良可能是监测的当务之急，而国际捐助者可能认为它的优 先程度低于传染病暴发。真正的伙伴关系可能需要改革全球卫生治理，将优先 事项从证券化、政治和贸易转向“普遍的健康价值观”［６３］。一般而言，数据收集 往往是在当地进行的，但数据分析却在州或国家一级进行的，因此对当地的反 馈很少。国际社会和各国政府都应鼓励地方一级分析和使用在当地收集的监测 数据。地方上分析和使用数据可以加强问责制，并改善促进人群健康的能力。当 地无法进行数据分析时，应将在中央或国家一级进行的分析与当地共享。 指南７：在规划、执行和使用监测数据时，应考虑社区的价值观和关 注点。 　　负责监测的官员、机构和组织，应设法事先让民众了解监测活动的目标、过 程和潜在影响（无论是积极的还是消极的），以显示对人的尊重。如果不能做到 或没有做到这一点，监测负责人必须意识到，他们的工作是在没有考虑到社会 关切的情况下进行的；监测负责人必须不仅成为全社会共同的善的管理者，也 成为各独立社区利益的管理者。当一项监测活动给特定人群造成不成比例的 负担时（例如污名化），参与就显得尤其重要。与社区，特别是与那些在历史上 被边缘化的社区接触，增强他们积极参与的能力就显得特别重要。鉴于一些公 共卫生监测活动需要在地方、国家和国际层面进行协调，并涉及多个参与方，社 区的积极参与和包容可能有助于建立或维持各级之间的信任，更有效率地开展 活动。 定义一个社区往往很难，因为地理区域并不是唯一的显著特征。而共同的 传统和价值观以及共同的身份可能是重要的决定性因素，健康状况也可能有助 于定义一个社区。 参与的适当性是辩论的另一个主题。一些倡导者将社区参与纳入监测的 ５２ 设计、实施、监督和评估环节。社区有必要参与传播监测成果，特别是在调查结 果可能导致污名化或歧视的情况下。对另一些人来说，对参与的承诺可能会更 加灵活。考虑社区价值观和关切需要合法当局按照善政原则，以透明的方式进 行公共卫生监测。社区的积极参与方式可能包括与社区负责人举行会议、重点 小组讨论和其他论坛，使参与成员有机会明确表达他们的价值观和关注（见指 南５和第Ⅲ部分中关于善政的讨论）。 　例２ :;<= 　　社区参与中一个特别令人信服和灵活的方法是民主审议。这是一种结构化的决策方法，将不同的利益相关者集中起来，为复杂的政策问题构 建解决方案。与会者参与讨论和对话，彼此尊重地交流他们的观点，并以 每个参与者都能理解的方式为他们的观点提供理由。其目的是在考虑经 验证据、社区生活经验和价值观的同时做出紧迫的决定。例如，美国生物 伦理委员会［６４］在处理令人焦虑的难题时，会使用审议的方法，并提供各种 培训工具［６５］。虽然民主审议只是确保公民参与的一种手段，并不适合所有 情况，但它不仅是地方和国家决策的主要方式，也是全球决策的主要方式。 例如，２０１６年６月，７６个国家的约１０００名公民对气候变化表示关切，并 建议采取具有法律约束力的措施，包括“报告各国适应和缓解气候变化所 做出的努力”，将全球变暖控制在２℃以下［６７］。 指南８：监测负责人员应在进行监测之前辨别、评估，尽量减少因披露 而造成伤害的风险。对伤害的监督应当是持续的，一旦发现就应采 取适当行动以减轻伤害。 　　即使公共卫生监测有明显正当理由，例如可以促进共同的善，成员国和负责 进行监测的人也应保持警惕，注意对个人和社区造成伤害的可能性（表１２）。 这并不意味着不应进行监测。相反，进行监测的国家有义务事先查明潜在 的伤害，监督监测期间和之后的伤害，并制定减轻伤害的程序。没有持续的监 督，减轻伤害是不可能的。这一点至关重要，因为这不仅会对个人和社区造成 伤害，如财产或旅游收入的损失，更有可能损害公众对该计划继而对整个公共 卫生的信任（见指南５、指南１２和指南１３以及第Ⅲ部分中关于善政的讨论）。 在某些情况下，国家应该对伴随监测而来的可能不可避免的伤害提供赔 偿。ＳＡＲＳ期间，中国台北给予被隔离人员相当于１４７美元［６８］的补偿。其他补 ６２ 偿方式还包括支付因监测而失业者的基本福利或病假工资。然而，补偿的可能 性不应成为监测的障碍［６９］。 监测可能带来许多不同类型的伤害：经济、法律、心理、社会（声誉）和身体 伤害。所有这些都应在监测方面加以考虑［７０７２］。例如，通过监测，迁徙者或另 一个弱势群体可能被认为具有较高的传染病风险，这可能导致对该群体的污名 化。必须非常谨慎地处理相关信息，否则会造成声誉很快受损以及一系列还未 被记录的、具有毁灭性后果的伤害。各种道德价值观和伦理原则应相互权衡， 并以透明的方式判断不同监测举措或监测系统中负担和利益的公平分配（见第 Ⅲ部分中关于公平和善政的讨论）。 监测者尽管为减轻伤害做出了各种努力，但当监测带来可预见的伤害风险 （污名化、歧视、驱逐或暴力）时，也应采取更多的预防措施，保护面临风险的个 人或社区。在罕见的情况下，造成严重伤害的风险可能非常大，以至于很难从 伦理上为监测活动辩护。然而，在大多数情况下，这种减轻伤害的策略可以确 保充分化解伤害风险。一旦确认存在伤害或潜在的伤害，就必须采取行动减少 伤害的风险，或必须制定计划以减少、消除或补偿伤害。 表１２　可能与披露公共卫生监测数据有关的伤害类型 伤害的类型 结果 身体的 公众的攻击、配偶／伴侣的虐待、家庭暴力、拖延或治疗不当 法律的 逮捕、起诉、死刑、驱逐 社会的 歧视、社区歧视、孤立、无法获得护理或要求护理却被拒绝、被社区拒绝 经济的 失业或收入的损失、健康保健服务的损失、保险的损失、保险费增加、健康保健费用增加、职业选择受限、生命资源的损失、被强迫搬迁 心理的／情绪上的痛苦、创伤、耻辱 由于并非所有伤害都可以消除，因此监测的收益应与伤害风险相称。保护 措施包括卫生部门应选择合适的方式向媒体和更广泛的公众公布信息或行动。 例如，对统计事实进行耸人听闻的陈述可能会对遭受健康问题影响的人或地区 造成声誉损害，延长其经济复苏期，例如被确定为传染病暴发源头的国家或社 区就存在这种情况。应制定程序和措施，以减轻监测造成的经济和其他方面的 伤害，将对社区的负面影响减少到最小，并保持信任。此外，鉴于国际人道主义 组织的任务是减轻伤害，在国内发生冲突的地区，政治中立的国际人道主义组 织绝不应受到阻碍。在这些地区，当国际机构认为反对党也是合作伙伴时，该 ７２ 机构就可能受到（当地政府的）限制［３］。 值得注意的是，公共卫生专业人员本身有时也需要保护。作为共同的善的 捍卫者，他们必须能够自由地报告监测数据，而不必担心遭到报复。由于监测 官员有责任直言不讳，他们应该受到保护。这一理念在《国际健康条例》中得到 确立，《国际健康条例》规定应该为那些在官方渠道以外报告可核实的疫情或公 共卫生事件的人员保密。 指南９：对那些特别容易受到疾病、伤害或不公正影响的个人或群体 进行监测极其重要，需要仔细审查，避免给他们增加不必要的额外 负担。 　　特别容易受伤害的个人或群体承受着过多的健康问题。负责任的当局应 竭尽全力，确保以赋予他们权力的方式将这些人群纳入监测。如何准确定义脆 弱性一直是文献中争论的主题［７４］。脆弱性可能是分散的，会影响到那些经济发 展有限，获得卫生保健设施受限，教育匮乏，遭受职业风险或有着更多不利条件 的大型社区。公共卫生监测和卫生信息系统可以提供有价值的信息，帮助制定 卫生规划和服务，以解决其健康问题和健康的基本决定因素，如清洁的水、食品 安全或性别平等。为促进公平，监测应关注这些弱势社区的具体问题。 特别易受疾病、伤害或不公正待遇影响的人，也会因监测活动及其结果而 承受进一步的负担，如歧视和耻辱。例如，疾病负担较高的难民群体和非法移 民，可能被错误地视为疾病暴发的原因。同样，患有矽肺病等职业病的工人，如 果得不到充分的法律支持，可能会被解雇，而不是接受治疗或赔偿。因此只要 有可能，就应在监测活动开始之前确定易受影响的群体，以便将伤害风险降至 最低。在监测活动中，应不断监督，尽可能避免对弱势群体造成（进一步）伤害。 在确实发生伤害时，应该采用减轻伤害的策略（见指南８）。 指南１０：各国政府和持有监测数据的其他机构必须确保可识别到个 人信息的数据得到适当的保护。 　　负责任的数据收集和共享的做法应确保所收集数据的安全，以尊重个人， 保障有关个人和社区的隐私和其他利益［５０］。各国政府和持有监测数据的其他 机构必须尽一切努力确保数据的安全，以防止未经授权的披露。安全性不同于 隐私和保密，但它是隐私和保密的重要组成部分。在这种情况下，安全性包括 操作性和技术性保障，以保护个人数据免受未经授权的访问或披露。维护信息 ８２ 安全不是万无一失的，因为电子数据库可能被入侵。 各国政府和持有监测数据的其他机构必须采取适当的技术和组织步骤，保 护数据免遭意外或未经授权的访问、销毁、丢失、使用或披露，无论这些数据是 以书面形式还是电子（数字）格式收集和存储的。所有能够获得公共卫生监测 数据的人员都应每年接受数据安全程序方面的培训，并意识到保护数据和公众 安全不仅是他们的职业道德，更是一种责任。考虑到目前的技术水平和成本， 安全级别必须与要保护数据的风险和性质相适应。特别是敏感信息增加了个 人和社区遭受污名化或歧视的风险，应受到特别严格的安全保护。 保护数据不能影响为合法公共卫生目的，有效使用或分享监测信息（见指 南１４～１７中关于分享的部分和指南２中关于有意义的伦理培训的讨论）。 指南１：在某些情况下，收集姓名或身份识别数据是合理的。 在某些情况下，收集姓名或身份识别数据在技术和伦理上都是必要的。有 效的监测可能需要消除重复的数据记录（即避免重复计算，这可能导致高估发 生率或流行率）。 姓名和其他唯一的身份识别信息（社会保障号码、身份证号码）对于纵向监 测登记可能是必不可少的，因为随着时间的推移，这些信息能够将一个人和／或 其亲属及联系人的记录正确联系起来。同样，有时候可能需要唯一的身份识别 信息将不同来源的数据联系起来（例如，结核病和艾滋病登记，或出生缺陷和寨 卡病毒感染登记）。关键的是，疫情暴发调查或病例跟踪和接触者追踪都需要 姓名和其他具体的身份识别信息（例如确认性传播疾病感染者的性伴侣或共针 伴侣并向其提供检测和治疗）。 对于是否可以使用唯一的身份识别信息取代姓名一直存在分歧。创建唯 一身份识别信息的成本很高，如果其构造方式允许准确的数据链接，则可以很 容易地链接回姓名。一些国家在最终采用实名系统前，尝试了艾滋病病毒感染 编码报告。虽然这些制度最初是唯一政治上可行的解决办法，但当发现这些制 度不符合联邦可靠性和有效性的资助标准时，就放弃了。然而，技术进步创造 了新的可能性，对载有唯一身份识别信息的数字数据进行加扰和加密，也许就 无法追踪到个人。善政要求，对使用实名而不是使用唯一身份识别信息或加密 技术的权衡，必须成为持续、透明和公开讨论的主题，同时要考虑监测系统的要 求、技术能力的变化、风险和有关唯一身份识别信息的规范演变以及这些信息 ９２ 的合法使用［７５］。 收集数据时，另一个重要的考虑因素是个人的地理位置，这可能是间接的 识别标志。在收集地理位置数据，以及在发布或分享全球定位系统数据时，优 先考虑保密性具有重要的伦理意义。收集数据应将地理信息屏蔽，将披露的风 险降至最小，保持空间分布但要阻止识别整群的精确地理坐标［７６］。 如果必须以实名或唯一身份认证信息收集数据，那么在规划程序时就应明确 这一要求。对实名的要求不仅在各国有不同的判断，在国家内部也可能不统一。 有时候，当地可能需要个人数据，而国家或国际上只要匿名或汇总数据就足够了。 指南１２：在需要可靠、有效、完整的数据集，并且相关保护措施到位时， 个人有义务为监测做出贡献。在这种情况下，伦理上不要求知情同意。 　　反对在未经知情同意的情况下进行公共卫生监测的历史由来已久。然而， 知情同意从来都不是公共卫生监测的默认规定。许多国家颁布了法律，要求监 测系统在未经同意的情况下收集个人数据，但须遵守法律规定的保障措施。 群体中的所有个人都有可能从监测项目中受益。因此，个人有互惠的义务 为监测做出贡献，从而促进共同的善。流行病学家ＧｅｏｆｒｅｙＲｏｓｅ的著名论断 指出，即使对每一个人的潜在好处很小，对社区的整体利益却可能很大［７］。群 体受益对个人应尽的伦理义务提出来要求。如果有选择退出的可能（太多的人 这样做），公共卫生就可能会受到不可估量的损害［７８］。在实践中，例如在人数很 多的情况下，寻求知情同意往往是不可行的。在风险较低的情况下，寻求知情 同意的费用可能高得令人望而却步，也是没有道理的（例如在一些流行病学研 究中，ＣＩＯＭＳ允许放弃知情同意）。然而，在某些情况下，同意是一种常态，例 如在例行的描述性健康调查中。负责监测的公共卫生部门有义务评估寻求知 情同意的重要性和可行性。这里必须说明的一点是，在需要知情同意的情况 下，同意必须是真正自愿的。 无论是否寻求知情同意，关于监测的性质和目的，以及可能造成的任何伤 害风险的信息，都应向公众传达（见指南１３）。相关的保护措施和充分的管理机 制（指南２和第Ⅲ部分中关于善政的讨论）、适当的伦理培训（指南２和指南６） 和数据安全（指南１０）将增强公众对监测系统的信任，并确保其安全。 ０３ 指南１３：必须向相关目标受众有效地传达监测结果。 向相关目标受众传达监测结果是一种令人信服的、得到广泛接受的伦理理 由，然而这并不能替代监测负责方去改善传播行动。在地方上，相关的目标受 众包括社区、社区官员和意见领袖、医疗卫生工作者（医生、护士和卫生工作 者）、决策者、卫生倡导者和卫生志愿者。此外，相关的目标受众还可包括成员 国、国家和国际机构，以及非政府组织。 虽然ＣＩＯＭＳ指南侧重于研究，但它们强调交流成果的重要性，无论是阳性 的还是阴性的，都可以“促进和加强公众讨论”。如果不向受众传达监测结果， 监测工作的社会价值就无法实现，那些收集监测等数据的工作人员就可能受到 指责，指责他们以共同的善的名义利用了那些参与收集和分析健康数据的个人 和群体。Ｎｕｆｉｅｌｄ生物伦理理事会认为，为了让参与数据收集的民众接受数据 公布的合理性，有必要让他们了解这些结果对保健和预防的影响［３５］。 传达监测结果的方式应简洁明了，让非专业受众可以理解并关注社区所关 心的问题（见指南７）。传达监测结果不应该引起恐慌，而应以明智的方式提醒 人们注意相关的风险。向收集和分析数据的社区和公众传递监测信息可能的 手段包括群发邮件、免费信息热线、社交媒体、报纸、研讨会和公开会议。在资 源有限的情况下，可以采用街头戏剧、民间艺术和其他以社区为基础的方式达 到相同的目的。传播还应为医生、医院管理人员和其他相关目标受众提供有意 义的信息。 知情是一把双刃剑：一方面，知情可以明确授权；另一方面，知情可能导致 伤害、污名化或歧视。在特殊情况下，决定不广泛公布数据可能是合理的，因为 公布可能会造成重大伤害。同样，如果受影响的人群非常小（例如非常罕见的 癌症病例），以至于能识别到具体个人，而且无论多么无意，都可能不可避免，则 可以限制交流以保护隐私［７９］。 决策者还必须权衡可能造成的伤害，如果受影响社区未被告知结果，也就 被剥夺了采取行动以减少风险的信息和能力为自身被污名化（见指南１３）。对 于更容易受到伤害或不公正待遇影响的个人和群体，负责公共卫生的人有义务 减轻沟通可能给这些人带来的负担。 设计和进行监测的负责人，何时在伦理上有责任（如果真有的话）向监测对 象告知个人的诊断结果，然后将其转交给适当的服务机构，这一点一直存在争 １３ 议［８０］。例如，在艾滋病流行初期，在没有治疗的情况下，盲法血清阳性率研究被 认为在伦理上是可以接受的。在这些以人群为基础的调查中，没有向研究的参 与者告知艾滋病病毒的感染状况。然而，随着艾滋病病毒诊断和管理技术的进 步，伦理共识发生了转变［８１］。指南目前建议监测系统需向知情同意的个人报告 结果［８０，８２８３］。指南还建议，在将结果反馈给个人后，应将那些有阳性结果的人 转诊到附近的医疗机构进行适当的临床评估、治疗和后续管理。此外，指南还 鼓励其伴侣参加检测［７６］和转诊，以获得社会心理支持。这个例子强调了监测系 统必须有一个参与其中的监督机构来处理这些问题，并根据其他法域的新证据 或新出现的最佳实践做出改变（指南２）。 在判断是否向个人反馈信息时，相关的伦理考虑包括可行性、采取行动的 可能性和对个人的潜在好处。 指南１４：在有适当保障措施和正当理由时，负责公共卫生监测的人员 有义务与其他国家和国际公共卫生机构共享数据。 　　公共卫生监测系统想实现有效、公平，并促进共同的善，就必须能够从负责 公共卫生的各类公共机构接收和连接数据。例如，由于ＨＩＶ监测具有严格的 数据安全要求，有些情况下ＨＩＶ的监测数据没有与负责结核病监测的人员共 享，从而排除了对合并感染病例的系统性识别。公共卫生工作人员在没有获得 准确数据的情况下，无法实时对传染病的迅速变化做出适当反应，也无法就慢 性病采取适当行动，对职业暴露也是如此。有一些例子表明，负责跟踪职业病 的机构没有与负责工人保护和工作场所监督的机构共享数据（尽管没有禁止数 据共享）［２３］。有文献综述表明，未能共享信息的主要原因是规划不善，而不是安 全问题。程序在共享数据方面遇到了技术困难，有些数据需要转换（例如将出 生年份转换为年龄）才能连接数据库［８４８５］。 公共卫生系统应建立相关准则，以便能够与其他国家和国际机构安全共享 数据（见指南１０）。为了避免利益损失或资源浪费，在伦理上需要尽早协调共享 流程。数据共享的伦理准则应尊重个人，确保只共享实现重要合法公共卫生目 所需的数据，不共享超出必要范围的数据，并确保随后没有与其他机构共享数 据，本指南规定的其他条件除外，例如指南１６～１７中规定的条件。当不同数据 的保护规定不一致时，应适用更严格的隐私标准。 ２３ 指南１５：在突发公共卫生事件期间，参与监测的所有各方都必须及时 共享数据。 　　收集和共享数据是普通公共卫生实践中的基本活动。在紧急情况下，数据 共享变得更加重要，因为局势紧迫，不完整或不断变化的信息存在不确定性，当 地卫生系统的应对能力不足，跨境合作的作用就显得尤为重要。这些原因使得 “在开展卫生应急时，数据的快速共享至关重要”［８６］。它不仅构成良好的公共卫 生实践，而且在伦理上是必要的。在符合伦理的情况下，迅速共享数据有助于 确定病因，预测疾病传播，评估现有的和新的疗法、对症治疗和预防措施，并指 导有限资源的部署。正如《世卫组织关于管理传染病暴发中的伦理问题的指 南》中［４９］所讨论的，对应急反应至关重要的临床和研究数据也应共享。数据共 享也是《国际健康条例》在突发卫生事件和传染病暴发中的一项义务。 作为持续的疾病流行前准备工作的一部分，各国应审查其关于数据共享的 法律、政策和实践，以确保这些法律、政策和实践可以充分保护个人信息，并处 理其他相关的伦理问题，如解决有关监测数据所有权或控制权的争议。各国应 努力确保迅速共享那些对保护公众健康和促进共同的善具有直接影响的监测 信息不会妨碍这些信息在随后的科学杂志上发表［８７］。 指南１６：在有适当理由和保障措施的情况下，公共卫生机构可以为了 研究目的使用和共享监测数据。 　　监测数据往往成为重要公共卫生研究的基础［８９０］。例如，癌症登记已被用 于进行生存和治疗效果的纵向流行病学研究。本指南认为可以允许从事研究 的科研人员共享监测数据，条件是这些研究：①对促进共同的善足够重要； ②如果没有所说的这些监测数据，研究工作就无法推进。对于哪些研究应该 被视为“足够重要”，以证明为研究目的而共享监测数据的合理性，有时可能会 存在分歧。这应该由地方政府、公共卫生部门和／或关于研究的伦理委员会（如 下所述）去判断，同时考虑到本指南列出的关注点。 为研究目的共享监测数据需要适当的保障措施，如伦理监督（见指南２）、匿 名化和数据安全。虽然适用于研究的伦理审查并不适用于公共卫生监测，但只 有经过适当的有关研究的伦理委员会，或其他相应机构审查和批准的研究项目 才能共享监测数据，而且要符合国际和地方关于研究的伦理行为标准。在做出 ３ 允许获取监测数据的决定时，伦理委员会应考虑此项研究对公共卫生的潜在影 响（研究是否足够重要，或者用ＣＩＯＭＳ的话来说，研究是否具有“社会价值”）、 对被监测对象的风险、保护隐私的措施，以及征求知情同意的重要性和可行性。 在确保数据安全和推进研究进展之间取得适当平衡有时会具有挑战性。 例如，在共享有关药物使用的敏感信息时，从给研究人员的个人临床记录中删除 所有有关药物滥用的信息，在阿片类药物广泛流行的背景下，这种以保护隐私为 名的做法已成为争议的焦点。一组批评者认为，这会让研究人员“毫无头绪”［９１］。 获得了监测数据的研究人员应向公共卫生部门告知他们的研究结果。在 与研究人员共享监测数据之前，应就以下问题达成一致——适当的数据使用、 对数据重新共享的限制、出版物中对数据源的充分感谢，以及在研究的最后阶 段数据销毁的条件。 指南１７：可识别个人身份的监测数据不应与下述机构共享，这些机构 可能利用这些数据采取针对个人的行动，或将数据用于与公共卫生 无关的用途。 　　虽然综合的公共卫生数据可能会广泛地共享给卫生部门以外的机构，或负 责公共福利的非国家参与者，但可识别个人身份的数据共享是一个完全不同的 概念。负责国家安全、执法或社会福利分配的机构通常只有在经过法律正当程 序的允许后，才可以获取此类个人信息。为了维护公众对公共卫生监测系统的 信任，为非公共卫生用途共享可识别身份的数据应当具有令人信服的理由。 在执法部门或其他机构涉嫌系统性地侵犯人权的国家，不适当的监测数据 共享尤其有争议。在这种背景下，与执法机构的合作可能会破坏公众对公共卫 生监测的信任，从而阻碍病人寻求医疗帮助或医疗卫生工作者诚实地报告数 据。这是处境特别弱势的个人或群体尤为关切的问题［９２］。此外，这种不合理的 共享有可能对公共卫生监测活动造成更广泛的长期损害。 指南２中建议的管理机制应确保共享可识别身份信息的例外条件（如果有 的话）明确而且透明。这种审查需要确定不共享可识别身份信息的威胁是否足 够严重，足以对公共卫生监测系统的完整性和信任造成潜在危害。必须制定制 裁措施，防止公共卫生机构不合理地共享数据，防止公共卫生部门以外的机构 不合理地使用数据。 ４３ Ⅴ　监测范围的变化 各种“非国家”行动者都可能会参与公共卫生监测，包括非政府组织、基于 信仰的组织、专业组织、研究机构、出资机构以及世卫组织和欧洲疾控中心等多 国联盟机构。公共监测职能甚至可能外包给私营公司，这可能就是令人担心的 原因，因为国家机构可能不再拥有也不能访问这些数据。然而，监测对象和范 围的变迁意味着任何一套伦理指南都必须跨越边界，不仅是国界，而且是传统 上将公众与私人分开的界限。 在大数据时代，模糊的边界问题变得更加复杂。这里所说的“大数据”，不 仅指现在可以收集和存储的数据量（通常是数字形式）增加，也指可用于快速处 理数据的计算能力增加。无处不在的个人电脑、智能手机、可穿戴电子设备、视 频监控机、基因测序仪、半自动无人机和其他技术意味着人们在源源不断地产 生数字数据。 一场以数据为中心的技术革命激发了人们对新兴的潜在利益的极大热情， 通过挖掘电子健康记录、基因组数据、生物材料、社交媒体通信、卫星图像和其 他数字数据集，可以识别新出现的疾病威胁，阻断食源性疾病的暴发，并改善公 共卫生组织之间的协作。无人机在疾病监测中被誉为“游戏规则改变者”。一 些人认为，无人机可以通过迅速识别逃离疫区的人群［９４９６］来精确定位疫情的暴 发。也有人对“无人机乌托邦主义”持怀疑态度，认为无人机监测不应成为资源 有限国家的卫生优先事项［９７］。 其他新技术，如艾滋病病毒的系统发育分析，也有类似的前景和危险，比 如使用或无法使用数据的利弊。目前个人设备可以收集并生成个人信息，但 当事人可能不知道这些数据后续的使用范围。目前尚不清楚私营部门是否 有义务与公共卫生机构或政府共享这些数据。这类数据的保管者应该意识 到可能出现的问题，参与关于合法数据共享的讨论，为监督风险和防止伤害 采取措施。 越来越多的人呼吁对与大数据有关的问题进行更多的研究和伦理分析［９８］。 大数据和数字疾病检测在公共卫生监测领域的地位仍未确定，应在隐私和匿 名、公共和私人数据集的整合，以及数据有效性和可靠性方面做更多的工作［９］。 ５３ 比尔和梅琳达·盖茨基金会负责监测和流行病学的副主任最近发出了一个重 要的呼吁：“我们需要伦理学者就其中一些问题开展工作”。 为了保持积极主动而不是被动，解决的问题必须代表下一个前沿。本指南 只是解决监测和大数据交叉问题的起点，但这种迅速变化的环境所带来的挑战 应该受到持续分析和伦理监督，国际社会必须应对这一挑战。 参考文献 ［１］ＳｕｓｔａｉｎａｂｌｅＤｅｖｅｌｏｐｍｅｎｔＧｏａｌｓ．ＮｅｗＹｏｒｋ，ＮＹ：ＵｎｉｔｅｄＮａｔｉｏｎｓ，２０１５（ｈｔｐ：∥ｗｗｗ．ｕｎ． ｏｒｇ／ｓｕｓｔａｉｎａｂｌｅｄｅｖｅｌｏｐｍｅｎｔ／ｓｕｓｔａｉｎａｂｌｅｄｅｖｅｌｏｐｍｅｎｔｇｏａｌｓ／，ａｃｅｓｅｄ１９Ｄｅｃｅｍｂｅｒ２０１６）． ［２］ＦａｉｒｃｈｉｌｄＡＬ，ＢａｙｅｒＲ，ＣｏｌｇｒｏｖｅＪＫ，ＷｏｌｆｅＤ．Ｓｅａｒｃｈｉｎｇｅｙｅｓ．Ｂｅｒｋｅｌｅｙ，ＣＡ：Ｕｎｉｖｅｒｓｉｔｙ ｏｆＣａｌｉｆｏｒｎｉａＰｒｅｓ，２０７． ［３］ＣａｌａｉｎＰ，ＳａＤａＣＡ．ＣｏｉｎｃｉｄｅｎｔｐｏｌｉｏａｎｄＥｂｏｌａｃｒｉｓｅｓｅｘｐｏｓｅｓｉｍｉｌａｒｆａｕｌｔｌｉｎｅｓｉｎｔｈｅ ｃｕｒｅｎｔｇｌｏｂａｌｈｅａｌｔｈｒｅｇｉｍｅ．ＣｏｎｆｌｉｃｔＨｅａｌｔｈ，２０１５，９：２９． ［４］ＳｅｌｇｅｌｉｄＭＪ．Ｂｉｏｅｔｈｉｃｓ．ＮｅｗＹｏｒｋ，ＮＹ：Ｍａｃｍｉｌａｎ，２０１４． ［５］ＷＨＯｈａｎｄｂｏｋｆｏｒｇｕｉｄｅｌｉｎｅｄｅｖｅｌｏｐｍｅｎｔ．Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ，２０１４． ［６］ＤｅｃｌｉｃｈＳ，ＣａｒｔｅｒＡＯ．Ｐｕｂｌｉｃｈｅａｌｔｈｓｕｒｖｅｉｌａｎｃｅ：ｈｉｓｔｏｒｉｃａｌｏｒｉｇｉｎｓ，ｍｅｔｈｏｄｓａｎｄ ｅｖａｌｕａｔｉｏｎ．ＢｕｌＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ，１９４，７２：２８５３０４． ［７］ＩｎｓｔｉｕｔｅｏｆＭｅｄｉｃｎｅ．Ａｄｒｅｓｉｎｇｆｏｄｂｏｒｎｅｔｈｒｅａｔｓｔｏｈｅａｌｔｈ：ｐｏｌｉｃｅｓ，ｐｒａｃｔｉｃｅｓ，ａｎｄ ｇｌｏｂａｌｃｏｒｄｉｎａｔｉｏｎ．Ｗｏｒｋｓｈｏｐｓｕｍｍａｒｙ．ＷａｓｈｉｎｇｔｏｎＤＣ：ＮａｔｉｏｎａｌＡｃａｄｅｍｉｅｓＰｒｅｓ，２０６． ［８］ＷＨＯｈｅａｌｔｈｔｏｐｉｃｓ｜Ｐｕｂｌｉｃｈｅａｌｔｈｓｕｒｖｅｉｌａｎｃｅ．Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ，２０１４ （ｈｔｐ：∥ｗｗ．ｗｈｏ．ｉｎｔ／ｔｏｐｉｃｓ／ｐｕｂｌｉｃ＿ｈｅａｌｔｈ＿ｓｕｒｖｅｉｌａｎｃｅ／ｅｎ／，ａｃｅｓｅｄ１９Ｄｅｃｅｍｂｅｒ２０１６）． ［９］Ｉｎｔｅｒｎａｔｉｏｎａｌｈｅａｌｔｈｒｅｇｕｌａｔｉｏｎｓ．３ｒｄＥｄｉｔｏｎ．Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ，２０５． ［１０］Ａｒｅａｓｕｒｖｅｉｌａｎｃｅ．ＢｕｅｎｏｓＡｉｒｅｓ：ＭｉｎｉｓｔｒｙｏｆＨｅａｌｔｈ，２０１７（ｈｔｐ：∥ｗｗｗ．ｍｓａｌ．ｇｏｂ．ａｒ／ ｉｎｄｅｘ．ｐｈｐ／ｈｏｍｅ／ｆｕｎｃｉｏｎｅｓ／ａｒｅａｄｅｖｉｇｉｌａｎｃｉａ）． ［１］ＯＣａｒｏｌＰＷ．Ｐｕｂｌｉｃｈｅａｌｔｈｉｎｆｏｒｍａｔｉｃｓａｎｄｉｎｆｏｒｍａｔｉｏｎｓｙｓｔｅｍｓ．ＮｅｗＹｏｒｋ，ＮＹ： Ｓｐｒｉｎｇｅｒ，２０３． ［１２］ＬｅＬＭ，ＴｈａｃｋｅｒＳＢ．Ｐｕｂｌｉｃｈｅａｌｔｈｓｕｒｖｅｉｌａｎｃｅａｎｄｋｎｏｗｉｎｇａｂｏｕｔｈｅａｌｔｈｉｎｔｈｅ ｃｏｎｔｅｘｔｏｆｇｒｏｗｉｎｇｓｏｕｒｃｅｓｏｆｈｅａｌｔｈｄａｔａ．ＡｍＪＰｒｅｖＭｅｄ，２０１，４１：６３６６４０． ［１３］ＳｕｒｖｅｉｌａｎｃｅｓｙｓｔｅｍｓｒｅｐｏｒｔｅｄｉｎＣｏｍｍｕｎｉｃａｂｌｅＤｉｓｅａｓｅｓＩｎｔｅｌｉｇｅｎｃｅ，２０１６．Ｃａｎｂｅｒａ： ＡｕｓｔｒａｌｉａｎＧｏｖｅｒｎｍｅｎｔＤｅｐａｒｔｍｅｎｔｏｆＨｅａｌｔｈ，２０１６（ｈｔｐ：∥ｗｗｗ．ｈｅａｌｔｈ．ｇｏｖ．ａｕ／ｉｎｔｅｒｎｅｔ／ ｍａｉｎ／ｐｕｂｌｉｓｈｉｎｇ．ｎｓｆ／Ｃｏｎｔｅｎｔ／ｃｄａｓｕｒｖｅｉｌｓｕｒｖ＿ｓｙｓ．ｈｔｍ）． ［１４］ＢｏｒｇｄｏｒｆＭＷ，ＭｏｔａｒｊｅｍｉＹ．Ｓｕｒｖｅｉｌａｎｃｅｏｆｏｄｂｏｒｎｅｄｉｓｅａｓｅｓ：Ｗｈａｔａｒｅｔｈｅｏｐｔｉｏｎｓ？ Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ，１９７． ［１５］ＤａｎｃｉｕＩ，ＣｏｗａｎＪＤ，ＢａｓｆｏｒｄＭ，ＷａｎｇＸ，ＳａｉｐＡ，ＯｓｇｏｄＳ，ｅｔａｌ．Ｓｅｃｏｎｄａｒｙｕｓｅｏｆ ｃｌｉｎｉｃａｌｄａｔａ：ｔｈｅＶａｎｄｅｒｂｉｌｔａｐｒｏａｃｈ．ＪＢｉｏｍｅｄＩｎｆｏｒｍａｔ，２０１４，５２：２８３５． ６３ ［１６］ＴａｔｅｍＡＪ，ＨｕａｎｇＺ，ＮａｒｉｂＣ，ＫｕｍａｒＵ，ＫａｎｄｕｌａＤ，ＰｉｎｄｏｌｉａＤＫ，ｅｔａｌ．Ｉｎｔｅｇｒａｔｉｎｇ ｒａｐｉｄｒｉｓｋｍａｐｉｎｇａｎｄｍｏｂｉｌｅｐｈｏｎｅｃａｌｒｅｃｏｒｄｄａｔａｆｏｒｓｔｒａｔｅｇｉｃｍａｌａｒｉａｅｌｉｍｉｎａｔｉｏｎ ｐｌａｎｉｎｇ．ＭａｌａｒＪ，２０１４，１３：５２． ［１７］ＷｅｓｏｌｏｗｓｋｉＡ，ＳｔｒｅｓｍａｎＧ，ＥａｇｌｅＮ，ＳｔｅｖｅｎｓｏｎＪ，ＯｗａｇａＣ，ＭａｒｕｂｅＥ，ｅｔａｌ． Ｑｕａｎｔｉｆｙｉｎｇｔｒａｖｅｌｂｅｈａｖｉｏｒｆｏｒｉｎｆｅｃｔｉｏｕｓｄｉｓｅａｓｅｒｅｓｅａｒｃｈ：ａｃｏｍｐａｒｉｓｏｎｏｆｄａｔａｆｒｏｍ ｓｕｒｖｅｙｓａｎｄｍｏｂｉｌｅｐｈｏｎｅｓ．ＳｃｉＲｅｐ，２０１４，４：５６７８． ［１８］ＬａｊｏｕｓＭ，ＤａｎｏｎＬ，ＬｏｐｅｚＲｉｄａｕｒａＲ，ＡｓｔｌｅｙＣＭ，ＭｉｌｅｒＪＣ，ＤｏｗｅｌＳＦ，ｅｔａｌ．Ｍｏｂｉｌｅ ｍｅｓａｇｉｎｇａｓｓｕｒｖｅｉｌａｎｃｅｔｏｌｄｕｒｉｎｇｐａｎｄｅｍｉｃ（Ｈ１Ｎ１）２０９，ＭｅｘｉｃｏＥｍｅｒｇＩｎｆｅｃｔＤｉｓ， ２０１０，１６：１４８１４８９． ［１９］Ｉｎｔｅｒｎａｔｉｏｎａｌｈｅａｌｔｈｒｅｇｕｌａｔｉｏｎｓ．Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ，１９８３． ［２０］ＲｅｐｏｒｔｏｆｔｈｅＥｂｏｌａｉｎｔｅｒｉｍａｓｅｓｍｅｎｔｐａｎｅｌ．Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ，２０１６ （ｈｔｐ：∥ｗｗｗ．ｗｈｏ．ｉｎｔ／ｃｓｒ／ｒｅｓｏｕｒｃｅｓ／ｐｕｂｌｉｃａｔｉｏｎｓ／ｅｂｏｌａ／ｒｅｐｏｒｔｂｙｐａｎｅｌ．ｐｄｆ？ｕａ＝１， ａｃｅｓｅｄ１９Ｄｅｃｅｍｂｅｒ２０１６）． ［２１］ＢａｌｄｗｉｎＰ．ＣｏｎｔａｇｉｏｎａｎｄｔｈｅｓｔａｔｅｉｎＥｕｒｏｐｅ，１８３０１９３０．Ｃａｍｂｒｉｄｇｅ：Ｃａｍｂｒｉｄｇｅ ＵｎｉｖｅｒｓｉｔｙＰｒｅｓ，１９９． ［２］ＴｅｕｔｓｃｈＳＭ，ＣｈｕｒｃｈｉｌＲＥ．Ｐｒｉｎｃｉｐｌｅｓａｎｄｐｒａｃｔｉｃｅｏｆｐｕｂｌｉｃｈｅａｌｔｈｓｕｒｖｅｉｌａｎｃｅ．Ｎｅｗ Ｙｏｒｋ：ＯｘｆｏｒｄＵｎｉｖｅｒｓｉｔｙＰｒｅｓ，１９４． ［２３］ＰｅｗＥｎｖｉｒｏｎｍｅｎｔａｌＨｅａｌｔｈＣｏｍｍｉｓｉｏｎ．ＴｒａｎｓｉｔｏｎＲｅｐｏｒｔｏｔｈｅＮｅｗＡｄｍｉｎｉｓｔｒａｔｉｏｎ： ＳｔｒｅｎｇｔｈｅｎｉｎｇＯｕｒＰｕｂｌｉｃＨｅａｌｔｈＤｅｆｅｎｓｅｓＡｇａｉｎｓｔＥｎｖｉｒｏｎｍｅｎｔａｌＴｈｒｅａｔｓ．Ｂａｌｔｉｍｏｒｅ： ＪｏｈｎｓＨｏｐｋｉｎｓＳｃｈｏｌｏｆＰｕｂｌｉｃＨｅａｌｔｈ，２０１． ［２４］ＣｏｍｍｕｎｉｃａｂｌｅｄｉｓｅａｓｅｓｓｕｒｖｅｉｌａｎｃｅｉｎＳｉｎｇａｐｏｒｅ２０１５．Ｓｉｎｇａｐｏｒｅ：Ｍｉｎｉｓｔｒｙｏｆ Ｈｅａｌｔｈ，２０１５． ［２５］Ｔｕｂｅｒｃｕｌｏｓｉｃｏｕｎｔｒｙｐｒｏｆｉｌｅ２０１５，Ｓｉｎｇａｐｏｒｅ．Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ， ２０１５． ［２６］ＭａｔｈｙｓＦ，ＶａｎｄｅｒＳｔｕｙｆｔＰ，ＶａｎＤｅｕｎＡ．Ｕｎｉｖｅｒｓａｌｔｕｂｅｒｃｕｌｏｓｉｃｏｎｔｒｏｌｔａｒｇｅｔｓ：ｎｏｔｓｏ ｓｍａｒｔ．ＩｎｔＪＴｕｂｅｒｃＬｕｎｇＤｉｓ，２０９，１３：９２３９２４． ［２７］ＫａｍａｌＳＭ，ＨｏｓａｉｎＡ，ＳｕｌｔａｎａＳ，ＢｅｇｕｍＶ，ＨａｑｕｅＮ，ＡｈｍｅｄＪ，ｅｔａｌ．Ａｎｔｉｔｕｂｅｒｃｕｌｏｓｉ ｄｒｕｇｒｅｓｉｔａｎｃｅｉｎＢａｎｇｌａｄｅｓｈ：ｒｅｆｌｅｃｔｉｏｎｓｆｒｏｍｔｈｅｆｉｒｓｔｎａｔｉｏｎｗｉｄｅｓｕｒｖｅｙ．ＩｎｔＪＴｕｂｅｒｃ ＬｕｎｇＤｉｓ，２０１５，１９：１５１１５６． ［２８］ＳｍｉｔｈＭＪ，ＳｉｌｖａＤＳ．Ｅｔｈｉｃｓｆｏｒｐａｎｄｅｍｉｃｓｂｅｙｏｎｄｉｎｆｌｕｅｎｚａ：Ｅｂｏｌａ，ｄｒｕｇｒｅｓｉｔａｎｔ ｔｕｂｅｒｃｕｌｏｓｉ，ａｎｄａｎｔｉｃｐａｔｉｎｇｆｕｔｕｒｅｅｔｈｉｃａｌｃｈａｌｅｎｇｅｓｉｎｐａｎｄｅｍｉｃｐｒｅｐａｒｅｄｎｅｓａｎｄ ｒｅｓｐｏｎｓｅ．ＭｏｎａｓｈＢｉｏｅｔｈＲｅｖ，２０１５，３：１３０１４７． ［２９］ＬｅＬＭ，ＴｈａｃｋｅｒＳＢ，ＳｔＬｏｕｉｓＭＥ，ＴｅｕｔｓｃｈＳＭ．Ｐｒｉｎｃｉｐｌｅｓａｎｄｐｒａｃｔｉｃｅｏｆｐｕｂｌｉｃｈｅａｌｔｈ ｓｕｒｖｅｉｌａｎｃｅ．３ｒｄＥｄｉｔｏｎ．Ｏｘｆｏｒｄ：ＯｘｆｏｒｄＵｎｉｖｅｒｓｉｔｙＰｒｅｓ，２０１０． ［３０］ＦｏｘＲＣ．Ａｄｖａｎｃｅｄｍｅｄｉｃａｌｔｅｃｈｎｏｌｏｇｙｓｏｃｉａｌａｎｄｅｔｈｉｃａｌｉｍｐｌｉｃａｔｉｏｎｓ．ＡｎｕＲｅｖ Ｓｏｃｉｏｌ，１９７６，２：２３１２６８． ［３１］ＦｏｘＲＣ，ＳｗａｚｅｙＪＰ．Ｍｅｄｉｃａｌｍｏｒａｌｉｔｙｉｓｎｏｔｂｉｏｅｔｈｉｃｓ：ｍｅｄｉｃａｌｅｔｈｉｃｓｉｎＣｈｉｎａａｎｄｔｈｅ ＵｎｉｔｅｄＳｔａｔｅｓ．ＮｅｗＢｒｕｎｓｗｉｃｋ，ＮＪ：ＴｒａｎｓａｃｔｉｏｎＢｏｋｓ，１９８． ［３２］ＲｏｔｈｍａｎＪＤ．Ｓｔｒａｎｇｅｒｓａｔｔｈｅｂｅｄｓｉｄｅ：ａｈｉｓｔｏｒｙｏｆｈｏｗｌａｗａｎｄｂｉｏｅｔｈｉｃｓｔｒａｎｓｆｏｒｍｅｄ ｍｅｄｉｃａｌｄｅｃｉｓｏｎｍａｋｉｎｇ．ＮｅｗＹｏｒｋ，ＮＹ：ＢａｓｉｃＢｏｋｓ，１９１． ７３ ［３］ＡｃｋｅｒｍａｎＨＴ．ＣｈｏｓｉｎｇｂｅｔｗｅｎＮｕｒｅｍｂｅｒｇａｎｄｔｈｅＮａｔｉｏｎａｌＣｏｍｍｉｓｉｏｎ：ｂａｌａｎｃｉｎｇｏｆ ｍｏｒａｌｐｒｉｎｃｉｐｌｅｓｉｎｃｌｉｎｉｃａｌｒｅｓｅａｒｃｈ．Ｉｎ：Ｔｈｅｅｔｈｉｃｓｏｆｒｅｓｅａｒｃｈｉｎｖｏｌｖｉｎｇｈｕｍａｎ ｓｕｂｊｅｃｔｓ：ｆａｃｉｎｇｔｈｅ２１ｓｔｃｅｎｔｕｒｙ．Ｆｒｅｄｅｒｉｃｋ，ＭＤ：ＵｎｉｖｅｒｓｉｔｙＰｕｂｌｉｓｈｉｎｇＧｒｏｕｐ，１９６． ［３４］Ｉｎｔｅｒｎａｔｉｏｎａｌｇｕｉｄｅｌｉｎｅｓｆｏｒｅｔｈｉｃａｌｒｅｖｉｅｗｏｆｅｐｉｄｅｍｉｏｌｏｇｉｃａｌｓｔｕｄｉｅｓ．Ｇｅｎｅｖａ；Ｃｏｕｎｃｉｌｆｏｒ ＩｎｔｅｒｎａｔｉｏｎａｌＯｒｇａｎｉｚａｔｉｏｎｓｏｆＭｅｄｉｃａｌＳｃｉｅｎｃｅｓ，１９１． ［３５］Ｉｎｔｅｒｎａｔｉｏｎａｌｅｔｈｉｃａｌｇｕｉｄｅｌｉｎｅｓｆｏｒｅｐｉｄｅｍｉｏｌｏｇｉｃａｌｓｔｕｄｉｅｓ．Ｇｅｎｅｖａ；Ｃｏｕｎｃｉｌｆｏｒ ＩｎｔｅｒｎａｔｉｏｎａｌＯｒｇａｎｉｚａｔｉｏｎｓｏｆＭｅｄｉｃａｌＳｃｉｅｎｃｅｓ，２０９． ［３６］ＨｅｐｌｅＢ．ＮｕｆｉｅｌｄＣｏｕｎｃｉｌｏｎＢｉｏｅｔｈｉｃｓ．Ｐｕｂｌｉｃｈｅａｌｔｈ：ｅｔｈｉｃａｌｉｓｕｅｓ．Ｌｏｎｄｏｎ：Ｎｕｆｉｅｌｄ ＣｏｕｎｃｉｌｏｎＢｉｏｅｔｈｉｃｓ，２０７． ［３７］Ｅｔｈｉｃｓｉｎｅｐｉｄｅｍｉｃｓ，ｅｍｅｒｇｅｎｃｉｅｓａｎｄｄｉｓａｓｔｅｒｓ：ｒｅｓｅａｒｃｈ，ｓｕｒｖｅｉｌａｎｃｅａｎｄｐａｔｉｅｎｔｃａｒｅ： ＷＨＯｔｒａｉｎｉｎｇｍａｎｕａｌ．Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ，２０１５． ［３８］ＲｕｂｅｌＡ．Ｊｕｓｔｉｆｙｉｎｇｐｕｂｌｉｃｈｅａｌｔｈｓｕｒｖｅｉｌａｎｃｅ：ｂａｓｉｃｉｎｔｅｒｅｓｔｓ，ｕｎｒｅａｓｏｎａｂｌｅｅｘｅｒｃｉｓｅ，ａｎｄｐｒｉｖａｃｙ． ＫｅｎｅｄｙＩｎｓｔＥｔｈｉｃｓＪ，２０１２，２：１３． ［３９］ＦａｉｒｃｈｉｌｄＡＬ．ＤｅａｌｉｎｇｗｉｔｈＨｕｍｐｔｙＤｕｍｐｔｙ：ｒｅｓｅａｒｃｈ，ｐｒａｃｔｉｃｅ，ａｎｄｔｈｅｅｔｈｉｃｓｏｆｐｕｂｌｉｃ ｈｅａｌｔｈｓｕｒｖｅｉｌａｎｃｅ．ＪＬａｗＭｅｄＥｔｈｉｃｓ，２０３，３１：６１５６２３． ［４０］ＤａｗｓｏｎＡ，ＪｅｎｉｎｇｓＢ．Ｔｈｅｐｌａｃｅｏｆｓｏｌｉｄａｒｉｔｙｉｎｐｕｂｌｉｃｈｅａｌｔｈｅｔｈｉｃｓ．ＰｕｂｌｉｃＨｅａｌｔｈ Ｒｅｖ，２０１３，３４：６５７９． ［４１］ＢｅａｕｃｈａｍｐＤＥ．Ｔｈｅｈｅａｌｔｈｏｆｔｈｅｒｅｐｕｂｌｉｃ：ｅｐｉｄｅｍｉｃｓ，ｍｅｄｉｃｎｅ，ａｎｄｍｏｒａｌｉｓｍａｓ ｃｈａｌｅｎｇｅｓｔｏｄｅｍｏｃｒａｃｙ．Ｐｈｉｌａｄｅｌｐｈｉａ，ＰＡ：ＴｅｍｐｌｅＵｎｉｖｅｒｓｉｔｙＰｒｅｓ，１９０． ［４２］ＵｐｓｈｕｒＲＥ．Ｐｒｉｎｃｉｐｌｅｓｆｏｒｔｈｅｊｕｓｔｉｆｃａｔｉｏｎｏｆｐｕｂｌｉｃｈｅａｌｔｈｉｎｔｅｒｖｅｎｔｉｏｎ．ＣａｎＪＰｕｂｌｉｃＨｅａｌｔｈ， ２０２，９３：１０１１０３． ［４３］ＫａｕｌＩ，ＦａｕｓｔＭ．Ｇｌｏｂａｌｐｕｂｌｉｃｇｏｄｓａｎｄｈｅａｌｔｈ：ｔａｋｉｎｇｔｈｅａｇｅｎｄａｆｏｒｗａｒｄ．ＢｕｌＷｏｒｌｄ ＨｅａｌｔｈＯｒｇａｎ，２０１，７９：８６９８７４． ［４］ＳｅｌｇｅｌｉｄＭＪ．Ｉｎｆｅｃｔｉｏｕｓｄｉｓｅａｓｅｅｔｈｉｃｓ：ｌｉｍｉｔｎｇｌｉｂｅｒｔｙｉｎｃｏｎｔｅｘｔｓｏｆｃｏｎｔａｇｉｏｎ．Ｎｅｗ Ｙｏｒｋ，ＮＹ：Ｓｐｒｉｎｇｅｒ，２０１． ［４５］ＤｅｎｅｕｌｉｎＳ，ＴｏｗｎｓｅｎｄＮ．Ｐｕｂｌｉｃｇｏｄｓ，ｇｌｏｂａｌｐｕｂｌｉｃｇｏｄｓａｎｄｔｈｅｃｏｍｍｏｎｇｏｄ．ＩｎｔＪ ＳｏｃＥｃｏｎ，２０７，３４：１９３６． ［４６］Ｃｌｏｓｉｎｇｔｈｅｇａｐｉｎａｇｅｎｅｒａｔｉｏｎ：ｈｅａｌｔｈｅｑｕｉｔｙｔｈｒｏｕｇｈａｃｔｉｏｎｏｎｔｈｅｓｏｃｉａｌｄｅｔｅｒｍｉｎａｎｔｓ ｏｆｈｅａｌｔｈ：ｆｉｎａｌｒｅｐｏｒｔｏｆｔｈｅｃｏｍｍｉｓｉｏｎｏｎｓｏｃｉａｌｄｅｔｅｒｍｉｎａｎｔｓｏｆｈｅａｌｔｈ．Ｇｅｎｅｖａ：Ｗｏｒｌｄ ＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ，２０８． ［４７］Ｇｕｉｄａｎｃｅｏｎｅｔｈｉｃｓｏｆｔｕｂｅｒｃｕｌｏｓｉｐｒｅｖｅｎｔｉｏｎ，ｃａｒｅａｎｄｃｏｎｔｒｏｌ．Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈ Ｏｒｇａｎｉｚａｔｉｏｎ，２０１０． ［４８］ＥｔｈｉｃｓｇｕｉｄａｎｃｅｆｏｒｔｈｅｉｍｐｌｅｍｅｎｔａｔｉｏｎｏｆｔｈｅｅｎｄＴＢｓｔｒａｔｅｇｙ．Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈ Ｏｒｇａｎｉｚａｔｉｏｎ，２０１７． ［４９］Ｇｕｉｄａｎｃｅｆｏｒｍａｎａｇｉｎｇｅｔｈｉｃａｌｉｓｕｅｓｉｎｉｎｆｅｃｔｉｏｕｓｄｉｓｅａｓｅｏｕｔｂｒｅａｋｓ．Ｇｅｎｅｖａ：Ｗｏｒｌｄ ＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ，２０１６． ［５０］ＳｃｏｔＪＣ．Ｓｅｉｎｇｌｉｋｅａｓｔａｔｅ：ｈｏｗｃｅｒｔａｉｎｓｃｈｅｍｅｓｔｏｉｍｐｒｏｖｅｔｈｅｈｕｍａｎｃｏｎｄｉｔｏｎｈａｖｅ ｆａｉｌｅｄ．ＮｅｗＨａｖｅｎ，ＣＴ：ＹａｌｅＵｎｉｖｅｒｓｉｔｙＰｒｅｓ，１９８． ［５１］Ｐｒｏｍｏｔｉｎｇｔｈｅｈｅａｌｔｈｏｆｒｅｆｕｇｅｓａｎｄｍｉｇｒａｎｔｓ．ＥｘｅｃｕｔｉｖｅＢｏａｒｄｒｅｓｏｌｕｔｉｏｎ１４０／２４．Ｇｅｎｅｖａ： ＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ，２０１７． ８３ ［５２］ＷｉｌｉｓｏｎＤＪ，ＯｎｄｒｕｓｅｋＮ，ＤａｗｓｏｎＡ，ＥｍｅｒｓｏｎＣ，ＦｅｒｉｓＬＥ，ＳａｇｉｎｕｒＲ，ｅｔａｌ．Ｗｈａｔ ｍａｋｅｓｐｕｂｌｉｃｈｅａｌｔｈｓｔｕｄｉｅｓｅｔｈｉｃａｌ？Ｄｉｓｏｌｖｉｎｇｔｈｅｂｏｕｎｄａｒｙｂｅｔｗｅｎｒｅｓｅａｒｃｈａｎｄ ｐｒａｃｔｉｃｅ．ＢＭＣＭｅｄＥｔｈｉｃｓ，２０１４，１５：６１． ［５３］ＧｒａｈａｍＪ，ＡｍｏｓＢ，ＰｌｕｍｐｔｒｅＴ．ＰｒｉｎｃｉｐｌｅｓｆｏｒＧｏｄＧｏｖｅｒｎａｎｃｅｉｎｔｈｅ２１ｓｔＣｅｎｔｕｒｙ： ＰｏｌｉｃｙＢｒｉｅｆＮｏ．１５．Ｏｔａｗａ：ＩｎｓｔｉｕｔｅｏｎＧｏｖｅｒｎａｎｃｅ，１９３（Ａｖａｉｌａｂｌｅａｔ：ｈｔｐ：∥ｉｏｇ．ｃａ／ ｗｐｃｏｎｔｅｎｔ／ｕｐｌｏａｄｓ／２０１２／１２／２０３＿Ａｕｇｕｓｔ＿ｐｏｌｉｃｙｂｒｉｅｆ１５１．ｐｄｆ）． ［５４］ＵｎｉｔｅｄＮａｔｉｏｎｓＤｅｖｅｌｏｐｍｅｎｔＰｒｏｇｒａｍｍｅ．Ｃｈａｐｔｅｒ８：ＧｏｖｅｒｎａｎｃｅＰｒｉｎｃｉｐｌｅｓ，Ｉｎｓｔｉｕｔｉｏｎａｌ Ｃａｐａｃｉｔｙ，ａｎｄＱｕａｌｉｔｙ．ＩｎＴｏｗａｒｄｓｈｕｍａｎｒｅｓｉｌｅｎｃｅ：ｓｕｓｔａｉｎｉｎｇＭＤＧｐｒｏｇｒｅｓｉｎａｎａｇｅ ｏｆｅｃｏｎｏｍｉｃｕｎｃｅｒｔａｉｎｔｙ．ＮｅｗＹｏｒｋ：ＵｎｉｔｅｄＮａｔｉｏｎｓＤｅｖｅｌｏｐｍｅｎｔＰｒｏｇｒａｍｍｅ，２０１ （Ａｖａｉｌａｂｌｅａｔ：ｈｔｐ：∥ｗｗｗ．ｕｎｄｐ．ｏｒｇ／ｃｏｎｔｅｎｔ／ｕｎｄｐ／ｅｎ／ｈｏｍｅ／ｌｉｂｒａｒｙｐａｇｅ／ｐｏｖｅｒｔｙ ｒｅｄｕｃｔｉｏｎ／ｉｎｃｌｕｓｉｖｅ＿ｄｅｖｅｌｏｐｍｅｎｔ／ｔｏｗａｒｄｓ＿ｈｕｍａｎ＿ｒｅｓｉｌｅｎｃｅｓｕｓｔａｉｎｉｎｇｍｄｇｐｒｏｇｒｅｓ ｉｎａｎａｇｅｏｆｅｃｏｎｏｍｉｃｕｎ．ｈｔｍｌ５４）． ［５］Ｅｘｐｅｒｔｉｎｆｏｒｍａｔｉｏｎ．Ｔｏｋｙｏ：ＪａｐａｎＭｉｎｉｓｔｒｙｏｆＨｅａｌｔｈ，ＬａｂｏｕｒａｎｄＷｅｌｆａｒｅ（ｈｔｐ：∥ｗｗｗ． ｍｈｌｗ．ｇｏ．ｊｐ／ｂｕｎｙａ／ｋｅｎｋｏｕ／ｋｅｋａｋｕｋａｎｓｅｎｓｈｏｕ１／ｄｌ／０１＿ｋａｎｓｅｎｓｈｏ．ｐｄｆ）． ［５６］ＧｅｒｍａｎＲＲ，ＬｅＬＭ，ＨｏｒａｎＪＭ，ＭｉｌｓｔｅｉｎＲＬ，ＰｅｒｔｏｗｓｋｉＣＡ，ＷａｌｅｒＭＮ，ｅｔａｌ．Ｕｐｄａｔｅｄ ｇｕｉｄｅｌｉｎｅｓｆｏｒｅｖａｌｕａｔｉｎｇｐｕｂｌｉｃｈｅａｌｔｈｓｕｒｖｅｉｌａｎｃｅｓｙｓｔｅｍｓ：ｒｅｃｏｍｍｅｎｄａｔｉｏｎｓｆｒｏｍｔｈｅ ＧｕｉｄｅｌｉｎｅｓＷｏｒｋｉｎｇＧｒｏｕｐ．ＭＭＷＲＲｅｃｏｍｍＲｅｐ，２０１，５０：１３５；ｑｕｉｚＣＥ１７． ［５７］ＢｒｏｃｋＤＷ，ＷｉｋｌｅｒＤ．ＥｔｈｉｃａｌｃｈａｌｅｎｇｅｓｉｎｌｏｎｇｔｅｒｍｆｕｎｄｉｎｇｆｏｒＨＩＶ／ＡＩＤＳ．Ｈｅａｌｔｈ Ａｆ（Ｍｉｌｗｏｄ），２０９，２８：１６６１６７６． ［５８］ＤａｎｉｅｌｓＮ．Ａｃｏｕｎｔａｂｉｌｔｙｆｏｒｒｅａｓｏｎａｂｌｅｎｅｓ：ｅｓｔａｂｌｉｓｈｉｎｇａｆａｉｒｐｒｏｃｅｓｆｏｒｐｒｉｏｒｉｔｙ ｓｅｔｉｎｇｉｓｅａｓｉｅｒｔｈａｎａｇｒｅｉｎｇｏｎｐｒｉｎｃｉｐｌｅｓ．ＢＭＪ，２００，３２１：１３０１３０１． ［５９］ＯＮｅｉｌＯ．Ｔｒｕｓｔ，ｔｒｕｓｔｗｏｒｔｈｉｎｅｓａｎｄｔｒａｎｓｐａｒｅｎｃｙ．Ｂｒｕｓｅｌｓ：ＥｕｒｏｐｅａｎＦｏｕｎｄａｔｉｏｎ Ｃｅｎｔｒｅ，２０１５． ［６０］ＷＨＯｆｒａｍｅｗｏｒｋｃｏｎｖｅｎｔｉｏｎｏｎｔｏｂａｃｏｃｏｎｔｒｏｌ．Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ， ２０３． ［６１］ＵｎｉｔｅｄＮａｔｉｏｎｓｆｒａｍｅｗｏｒｋｃｏｎｖｅｎｔｉｏｎｏｎｃｌｉｍａｔｅｃｈａｎｇｅ．ＮｅｗＹｏｒｋ，ＮＹ：Ｕｎｉｔｅｄ Ｎａｔｉｏｎｓ，２０１５． ［６２］ＣａｌａｉｎＰ．Ｆｒｏｍｔｈｅｆｉｅｌｄｓｉｄｅｏｆｔｈｅｂｉｎｏｃｕｌａｒｓ：ａｄｉｆｅｒｅｎｔｖｉｅｗｏｎｇｌｏｂａｌｐｕｂｌｉｃｈｅａｌｔｈ ｓｕｒｖｅｉｌａｎｃｅ．ＨｅａｌｔｈＰｏｌｉｃｙＰｌａｎ，２０７，２：１３２０． ［６３］ＧｏｓｔｉｎＬ，ＦｒｉｅｄｍａｎＥＡ．Ｅｂｏｌａ：ａｃｒｉｓｉｎｇｌｏｂａｌｈｅａｌｔｈｌｅａｄｅｒｓｈｉｐ．Ｌａｎｃｅｔ，２０１４，３８４： １３２３１３２５． ［６４］ＢｉｏｅｔｈｉｃｓｆｏｒＥｖｅｒｙＧｅｎｅｒａｔｉｏｎ：ＴｈｅＰｒｅｓｉｄｅｎｔｉａｌＣｏｍｍｉｓｉｏｎｆｏｒｔｈｅＳｔｕｄｙｏｆＢｉｏｅｔｈｉｃａｌ Ｉｓｕｅｓ（Ａｖａｉｌａｂｌｅｆｒｏｍ：ｈｔｐｓ：∥ｂｉｏｅｔｈｉｃｓａｒｃｈｉｖｅ．ｇｅｏｒｇｅｔｏｗｎ．ｅｄｕ／ｐｃｓｂｉ／ｎｏｄｅ５６７８． ｈｔｍｌ）． ［６５］ＧｕｉｄｅｔｏＤｅｍｏｃｒａｔｉｃＤｅｌｉｂｅｒａｔｉｏｎｆｏｒＰｕｂｌｉｃＨｅａｌｔｈＰｒｏｆｅｓｉｏｎａｌｓ．Ｐｒｅｓｉｄｅｎｔｉａｌ ＣｏｍｍｉｓｉｏｎｆｏｒｔｈｅＳｔｕｄｙｏｆＢｉｏｅｔｈｉｃａｌＩｓｕｅｓ，２０１６． ［６］ＤｅｌｉｂｅｒａｔｉｖｅＳｃｅｎａｒｉｏｓ：ＰｒｅｓｉｄｅｎｔｉａｌＣｏｍｍｉｓｉｏｎｆｏｒｔｈｅＳｔｕｄｙｏｆＢｉｏｅｔｈｉｃａｌＩｓｕｅｓ，２０１６ （Ａｖａｉｌａｂｌｅｆｒｏｍ：ｈｔｐｓ：∥ｂｉｏｅｔｈｉｃｓａｒｃｈｉｖｅ．ｇｅｏｒｇｅｔｏｗｎ．ｅｄｕ／ｐｃｓｂｉ／ｎｏｄｅ５７０７．ｈｔｍｌ）． ［６７］ＷｏｒｌｄＷｉｄｅＶｉｅｗｓＯｎＣｌｉｍａｔｅＡｎｄＥｎｅｒｇｙＲｅｓｕｌｔｓＲｅｐｏｒｔ，ＷｏｒｌｄＷｉｄｅＶｉｅｗｓｏｎ ＣｌｉｍａｔｅａｎｄＥｎｅｒｇｙ，２０１５．（Ａｖａｉｌａｂｌｅｆｒｏｍ：ｈｔｐ：∥ｃｌｉｍａｔｅａｎｄｅｎｅｒｇｙ．ｗｗｖｉｅｗｓ．ｏｒｇ／ｗｐ ９３ ｃｏｎｔｅｎｔ／ｕｐｌｏａｄｓ／２０１５／０９／ＷＷｖｉｅｗｓＲｅｓｕｌｔＲｅｐｏｒｔ＿ｅｎｇｌｉｓｈ＿ｌｏｗ．ｐｄｆ）． ［６８］Ｕｓｅｏｆｑｕａｒａｎｔｉｎｅｔｏｐｒｅｖｅｎｔｒａｎｓｍｉｓｉｏｎｏｆｓｅｖｅｒｅａｃｕｔｅｒｅｓｐｉｒａｔｏｒｙｓｙｎｄｒｏｍｅ．Ｍｏｒｂｉｄ ＭｏｒｔａｌＷｋｌｙＲｅｐ，２０３，５２：６８０６８３． ［６９］ＧｏｓｔｉｎＬＯ，ＢａｙｅｒＲ，ＦａｉｒｃｈｉｌｄＬＡ．Ｅｔｈｉｃａｌａｎｄｌｅｇａｌｉｍｐｌｉｃａｔｉｏｎｓｐｏｓｅｄｂｙｓｅｖｅｒｅａｃｕｔｅ ｒｅｓｐｉｒａｔｏｒｙｓｙｎｄｒｏｍｅ：ｉｍｐｌｉｃａｔｉｏｎｓｆｏｒｔｈｅｃｏｎｔｒｏｌｏｆｓｅｖｅｒｅｉｎｆｅｃｔｉｏｕｓｄｉｓｅａｓｅｔｈｒｅａｔｓ．Ｊ ＡｍＭｅｄＡｓｏｃ，２０３，２９０：３２９３２３７． ［７０］ＭａｃＱｕｅｎＫＭ，ＭｃＬｅｌａｎＥ，ＭｅｔｚｇｅｒＤＳ，ＫｅｇｅｌｓＳ，ＳｔｒａｕｓＲＰ，ＳｃｏｔｉＲ，ｅｔａｌ．Ｗｈａｔｉｓ ｃｏｍｍｕｎｉｔｙ？Ａｎｅｖｉｄｅｎｃｅｂａｓｅｄｄｅｆｉｎｉｔｏｎｆｏｒｐａｒｔｉｃｐａｔｏｒｙｐｕｂｌｉｃｈｅａｌｔｈ．ＡｍＪＰｕｂｌｉｃＨｅａｌｔｈ， ２０１，９１：１９２９１９３８． ［７１］ＴｉｎｄａｎａＰＯ，ＳｉｎｇｈＪＡ，ＴｒａｃｙＣＳ，ＵｐｓｈｕｒＲＥ，ＤａｒＡＳ，ＳｉｎｇｅｒＰＡ，ｅｔａｌ．Ｇｒａｎｄ ｃｈａｌｅｎｇｅｓｉｎｇｌｏｂａｌｈｅａｌｔｈ：ｃｏｍｍｕｎｉｔｙｅｎｇａｇｅｍｅｎｔｉｎｒｅｓｅａｒｃｈｉｎｄｅｖｅｌｏｐｉｎｇｃｏｕｎｔｒｉｅｓ． ＰＬｏＳＭｅｄ，２０７，４：ｅ２７３． ［７２］ＺａｋｕｓＪＤ，ＬｙｓａｃｋＣＬ．Ｒｅｖｉｓｔｉｎｇｃｏｍｍｕｎｉｔｙｐａｒｔｉｃｐａｔｉｏｎ．ＨｅａｌｔｈＰｏｌｉｃｙＰｌａｎ，１９８， １３：１１２． ［７３］ＧｒａｅｍｅＬ，ＳｔｅｖｅｎｓＬ，ＪｏｎｅｓＫＨ，ＤｏｂｓＣ．Ａｒｅｖｉｅｗｏｆｅｖｉｄｅｎｃｅｒｅｌａｔｉｎｇｔｏｈａｒｍ ｒｅｓｕｌｔｉｎｇｆｒｏｍｕｓｅｓｏｆｈｅａｌｔｈａｎｄｂｉｏｍｅｄｉｃａｌｄａｔａ．Ｏｘｆｏｒｄ：ＮｕｆｉｅｌｄＣｏｕｎｃｉｌｏｎ Ｂｉｏｅｔｈｉｃｓ，２０１５． ［７４］ＢａｒｅｔＤＨ，ＯｒｔｍａｎＬＨ，ＤａｗｓｏｎＡ，ＳａｅｎｚＣ，ＲｅｉｓＡ，ＢｏｌａｎＧ．Ｐｕｂｌｉｃｈｅａｌｔｈｅｔｈｉｃｓ： ｃａｓｅｓｓｐａｎｉｎｇｔｈｅｇｌｏｂｅ．ＳｐｒｉｎｇｅｒＯｐｅｎ，２０１６． ［７５］Ｃｏｎｓｉｄｅｒａｔｉｏｎｓａｎｄｇｕｉｄａｎｃｅｆｏｒｃｏｕｎｔｒｉｅｓａｄｏｐｔｉｎｇｎａｔｉｏｎａｌｈｅａｌｔｈｉｄｅｎｔｉｆｅｒｓ．Ｇｅｎｅｖａ： ＵＮＡＩＤＳ，２０１４（ｈｔｐ：∥ｗｗｗ．ｕｎａｉｄｓ．ｏｒｇ／ｓｉｔｅｓ／ｄｅｆａｕｌｔ／ｆｉｌｅｓ／ｍｅｄｉａ＿ａｓｅｔ／ＪＣ２６４０＿ ｎａｔｉｏｎａｌｈｅａｌｔｈｉｄｅｎｔｉｆｅｒｓ＿ｅｎ．ｐｄｆ）． ［７６］ＭｏｎｉｔｏｒｉｎｇＨＩＶｉｍｐａｃｔｕｓｉｎｇｐｏｐｕｌａｔｉｏｎｂａｓｅｄｓｕｒｖｅｙｓ．Ｇｅｎｅｖａ：ＵＮＡＩＤＳ，２０１５． ［７］ＲｏｓｅＧ．Ｓｉｃｋｉｎｄｉｖｉｄｕａｌｓａｎｄｓｉｃｋｐｏｐｕｌａｔｉｏｎｓ．ＩｎｔＪＥｐｉｄｅｍｉｏｌ，１９８５，１４：３２３８． ［７８］ＵｐｓｈｕｒＲＥ，ＭｏｒｉｎＢ，ＧｏｅｌＶ．Ｔｈｅｐｒｉｖａｃｙｐａｒａｄｏｘ：ｌａｙｉｎｇＯｒｗｅｌｓｇｈｏｓｔｔｏｒｅｓｔ．Ｃａｎ ＭｅｄＡｓｏｃＪ，２０１，１６５：３０７３０９． ［７９］ＤａｖｉｓｏｎＷＬ，ＫｅｌｅｙＲＡ．ＩＣＥＳｒｅｐｏｒｔ—２０１４ｐｒｅｓｃｒｉｂｅｄｅｎｔｉｙｒｅｖｉｅｗ．Ｔｏｒｏｎｔｏ， Ｏｎｔａｒｉｏ：ＩｎｓｔｉｕｔｅｆｏｒＣｌｉｎｉｃａｌＥｖａｌｕａｔｉｖｅＳｃｉｅｎｃｅｓ，２０１４． ［８０］ＢａｇａｌｅｙＲ，ＪｏｈｎｓｏｎＣ，ＧａｒｃｉａＣａｌｅｊａＪＭ，ＳａｂｉｎＫ，ＯｂｅｒｍｅｙｅｒＣ，ＴａｅｇｔｍｅｙｅｒＭ，ｅｔａｌ． Ｒｏｕｔｉｎｅｆｅｄｂａｃｋｏｆｔｅｓｔｒｅｓｕｌｔｓｔｏｐａｒｔｉｃｐａｎｔｓｉｎｃｌｉｎｉｃａｎｄｓｕｒｖｅｙｂａｓｅｄｓｕｒｖｅｉｌａｎｃｅｏｆ ＨＩＶ．ＢｕｌＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎ，２０１５，９３：３５２３５． ［８１］ＦａｉｒｃｈｉｌｄＬＡ，Ｒｏｎａｌｄ．ＵｎｌｉｎｋｅｄａｎｏｎｙｍｏｕｓｔｅｓｔｉｎｇｆｏｒＨＩＶｉｎｄｅｖｅｌｏｐｉｎｇｃｏｕｎｔｒｉｅｓ：ａｎｅｗ ｅｔｈｉｃａｌｃｏｎｓｅｎｓｕｓ．ＰｕｂｌｉｃＨｅａｌｔｈＲｅｐ，２０１２，１２７：１５１８． ［８２］ＣｏｎｓｏｌｉｄａｔｅｄｇｕｉｄｅｌｉｎｅｓｏｎＨＩＶｔｅｓｔｉｎｇｓｅｒｖｉｃｅｓ．Ｇｅｎｅｖａ：ＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎｉｚａｔｉｏｎ， ２０１５． ［８３］ＭｏｎｉｔｏｒｉｎｇＨＩＶｉｍｐａｃｔｕｓｉｎｇｐｏｐｕｌａｔｉｏｎｂａｓｅｄｓｕｒｖｅｙｓ．Ｇｅｎｅｖａ：ＵＮＡＩＤＳ，２０１５． ［８４］ＢｅｒｎｓｔｅｉｎＡＢ，ＳｗｅｎｅｙＭＨ．Ｐｕｂｌｉｃｈｅａｌｔｈｓｕｒｖｅｉｌａｎｃｅｄａｔａ：ｌｅｇａｌ，ｐｏｌｉｃｙ，ｅｔｈｉｃａｌ， ｒｅｇｕｌａｔｏｒｙ，ａｎｄｐｒａｃｔｉｃａｌｉｓｕｅｓ．ＭＭＷＲＳｕｐｌ，２０１２，６１：３０３４． ［８５］ＫｌｉｎｇｌｅｒＣ，ＳｉｌｖａＤ，ＳｃｈｕｅｒｍａｎＣ，ＲｅｉｓＡ，ＳａｘｅｎａＡ，ＳｔｒｅｃｈＤ．Ｅｔｈｉｃａｌｉｓｕｅｓｉｎｐｕｂｌｉｃ ｈｅａｌｔｈｓｕｒｖｅｉｌａｎｃｅ：ａｓｙｓｔｅｍａｔｉｃｒｅｖｉｅｗ．ＢＭＣＰｕｂｌｉｃＨｅａｌｔｈ，２０１７，４：１７（１）：２９５． ０４ ［８６］ＤｙｅＣ，ＢａｒｔｏｌｏｍｅｏｓＫ，ＭｏｒｔｈｙＶ，ＫｉｅｎｙＭＰ．Ｄａｔａｓｈａｒｉｎｇｉｎｐｕｂｌｉｃｈｅａｌｔｈ ｅｍｅｒｇｅｎｃｉｅｓ：ａｃａｌｔｏｒｅｓｅａｒｃｈｅｒｓ．ＢｕｌＷｏｒｌｄＨｅａｌｔｈＯｒｇａｎ，２０１６，９４：１５８． ［８７］ＬａｎｇａｔＰ，ＰｉｓａｒｔｃｈｉｋＤ，ＳｉｌｖａＤ，ＢｅｒｎａｒｄＣ，ＯｌｓｅｎＫ，ＳｍｉｔｈＭ，ｅｔａｌ．Ｉｓｔｈｅｒｅａｄｕｔｙｔｏ ｓｈａｒｅ？Ｅｔｈｉｃｓｏｆｓｈａｒｉｎｇｒｅｓｅａｒｃｈｄａｔａｉｎｔｈｅｃｏｎｔｅｘｔｏｆｐｕｂｌｉｃｈｅａｌｔｈｅｍｅｒｇｅｎｃｉｅｓ． ＰｕｂｌｉｃＨｅａｌｔｈＥｔｈｉｃｓ，２０１，４：４１． ［８］ＨｒｉｐｃｓａｋＧ，ＢｌｏｍｒｏｓｅｎＭ，ＦｌａｔｅｌｙＢｒｅｎａｎＰ，ＣｈｕｔｅＣＧ，ＣｉｍｉｎｏＪ，ＤｅｔｍｅｒＤＥ，ｅｔａｌ． Ｈｅａｌｔｈｄａｔａｕｓｅ，ｓｔｅｗａｒｄｓｈｉｐ，ａｎｄｇｏｖｅｒｎａｎｃｅ：ｏｎｇｏｉｎｇｇａｐｓａｎｄｃｈａｌｅｎｇｅｓ：ａｒｅｐｏｒｔ ｆｒｏｍＡＭＩＡｓ２０１２ｈｅａｌｔｈｐｏｌｉｃｙｍｅｔｉｎｇ．ＪＡｍＭｅｄＩｎｆｏｒｍＡｓｏｃ，２０１４，２１：２０４２１． ［８９］ＧｅｉｓｂｕｈｌｅｒＡ，ＳａｆｒａｎＣ，ＢｕｃｈａｎＩ，ＢｅｌａｚｉＲ，ＬａｂｋｏｆＳ，ＥｉｌｅｎｂｅｒｇＫ．Ｔｒｕｓｔｗｏｒｔｈｙ ｒｅｕｓｅｏｆｈｅａｌｔｈｄａｔａ：ａｔｒａｎｓｎａｔｉｏｎａｌｐｅｒｓｐｅｃｔｉｖｅ．ＩｎｔＪＭｅｄＩｎｆｏｒｍ，２０１３，８２：１９． ［９０］ＬｏｎｇｏＬＤ，ＤｒａｚｅｎＭＪ．Ｄａｔａｓｈａｒｉｎｇ．ＮＥｎｇｌＪＭｅｄ，２０１６，３７４：２７６２７． ［９１］ＦｒａｋｔＡＢ，ＢａｇｌｅｙＮ．Ｐｒｏｔｅｃｔｉｏｎｏｒｈａｒｍ？Ｓｕｐｒｅｓｉｎｇｓｕｂｓｔａｎｃｅｕｓｅｄａｔａ．ＮＥｎｇｌＪ Ｍｅｄ，２０１５，３７２：１８７９１８１． ［９２］ＳｉｄｅｌＶＷ，ＣｏｈｅｎＨＷ，ＧｏｕｌｄＲＭ．Ｇｏｄｉｎｔｅｎｔｉｏｎｓａｎｄｔｈｅｒｏａｄｔｏｂｉｏｔｅｒｏｒｉｓｍ ｐｒｅｐａｒｅｄｎｅｓ．ＡｍＪＰｕｂｌｉｃＨｅａｌｔｈ，２０１，９１：７１６７１８． ［９３］ＦａｔｉｍａＲ，ＨａｒｉｓＲＪ，ＥｎａｒｓｏｎＤＡ，ＨｉｎｄｅｒａｋｅｒＳＧ，ＱａｄｅｒＥ，ＡｌｉＫ，ｅｔａｌ．Ｅｓｔｉｍａｔｉｎｇ ｔｕｂｅｒｃｕｌｏｓｉｂｕｒｄｅｎａｎｄｃａｓｅｄｅｔｅｃｔｉｏｎｉｎＰａｋｉｓｔａｎ．ＩｎｔＪＴｕｂｅｒｃＬｕｎｇＤｉｓ，２０１４，１８：５６０． ［９４］ｉＨＬＳ．ＦｉｇｈｔｉｎｇＥｂｏｌａｕｓｉｎｇｄｒｏｎｅｓ，２０１４（ｈｔｐ：∥ｉｈｌｓ．ｃｏｍ／ａｒｃｈｉｖｅｓ／４０５１）． ［９５］ＡｔｈｅｒｔｏｎＫＤ．Ｔｈｅｗｅｋｉｎｄｒｏｎｅｓ：ｄｒｏｎｅｓｆｉｇｈｔＥｂｏｌａ，Ｉｒａｎｉａｎｄｏｇｆｉｇｈｔｅｒｓ，ａｎｄｍｏｒｅ． Ｋｅｐｉｎｇｕｐｗｉｔｈｔｈｅｄｒｏｎｅｓｅｓ．ＰｏｐｕｌａｒＳｃｉｅｎｃｅ，２０１４，９：２６． ［９６］ＴｈｅｒｍａｌｉｍａｇｉｎｇｃａｍｅｒａｓｆｉｇｈｔｉｎｇｔｈｅｗａｒｏｎＥｂｏｌａｖｉｒｕｓ．ＬａｓＶｅｇａｓ，ＮＶ：ＳｉｅｒａＰａｃｉｆｃ Ｉｎｏｖａｔｉｏｎｓ，２０１４（ｈｔｐｓ：∥ｗｗｗ．ｘ２０．ｏｒｇ／ｔｈｅｒｍａｌｉｍａｇｉｎｇｃａｍｅｒａｓｗａｒｅｂｏｌａ／）． ［９７］ＫｒｉｓｔｉｎＢＳ．Ａｆｒｉｃａｎｄｒｏｎｅｓｔｏｒｉｅｓ．ＢｅｈｅｍｏｔｈＪＣｉｖｉｌｓａｔｉｏｎ，２０１５，８：７３９６． ［９８］ＭｅｔｃａｌｆＪ，ＫｅｌｅｒＥ，ＢｏｙｄＤ．Ｐｒｅｓｐｃｔｉｖｅｏｎｂｉｇｄａｔａ，ｅｔｈｉｃｓａｎｄｓｏｃｉｅｔｙ．ＣｏｕｎｃｉｌｆｏｒＢｉｇ Ｄａｔａ，ＥｔｈｉｃｓａｎｄＳｏｃｉｅｔｙ，２０１６（ｈｔｐ：∥ｂｄｓ．ｄａｔａｓｏｃｉｅｔｙ．ｎｅｔ／ｕｐｃｏｎｔｅｎｔ／ｕｐｌｏａｄｓ／２０１６／ ０５／ＰｅｒｓｐｅｃｔｉｖｅｓｏｎＢｉｇＤａｔａ．ｐｄｆ）． ［９］ＶｅｙｅｎａＥ，ＳａｌａｔｈｅＭ，ＭａｄｏｆＬＣ，ＢｒｏｗｎｓｔｅｉｎＪＳ．Ｅｔｈｉｃａｌｃｈａｌｅｎｇｅｓｏｆｂｉｇｄａｔａｉｎ ｐｕｂｌｉｃｈｅａｌｔｈ．ＰｌｏｓＣｏｍｐｕｔＢｉｏｌ，２０１５，１：ｅ１０３９０４． 从事公共卫生监测的伦理义务是什么？ 进行疾病监测的风险是什么？这些风险该如何与人群层面的利益相 平衡？ 相关社区何时以及如何参与监测计划的制定？ 如何保护监测数据的隐私？ 公共卫生部门间共享，与公共卫生研究者共享，或与为监测做出贡献的 社区和个人共享相关监测数据的伦理义务是什么？ 在什么情况下，必须严格禁止分享数据？ 应建立什么机制以确保将伦理议题置于数据的收集、使用和发布之前？ 这些都是参与公共卫生监测的人士一个多世纪以来一直在努力解决的核 １４ 心问题。为了解决这些问题和其他紧迫问题，一个国际专家组制定了《世界卫 生组织关于公共卫生监测中伦理问题的指南》。基于一系列核心伦理和政策考 虑，这１７项指南确立了开展监测、共享数据和社区参与的积极义务，同时承认 监测的局限性。本指南适用于以基本的文化、经济和政治变化为特征的情况， 其目标是进行批判性的讨论，治理和监督监测活动。 ２４