Guidance For Managing Ethical Issues In Infectious Disease - Outbreaks
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Guidance For Managing
Ethical Issues
In Infectious Disease
Outbreaks
ethics
public health ethics
beneficence
privacy
autonomy
principle
public good
liberty
distributive justice
beneficence values
dignity
principle
bioethics
justice
utilitarianism
solidarity
solidarity
values
egalitarianism
reciprocity
value
egalitarianism
social justice
human rights
informed consent
confidentiality
liberty
procedural justice equity
principle
solidarity
dignity
non-maleficence
egalitarianism
value
principle
confidentiality
equity
equity
non-maleficence
values
proportionality equity
value
public good
public health ethics
liberty solidarity
value principle
principles
procedural justice
liberty
non-maleficence
value value
beneficence
public good
distributive justice
beneficence
public good equity
liberty
human rights
privacy
public good
bioethics
value
proportionality
liberty liberty
informed consent
bioethics
informed consent
liberty solidarity
social justice
dignity human rights distributive justice
confidentiality
human rights
reciprocity
equity
procedural justice
dignity
public health ethics
public health ethics
informed consent
public good
privacy
distributive justice
principles
beneficence
principle equity principle
justice social justice
confidentiality
dignity
value solidarity
bioethics
public health ethics
value
procedural justice equity principle
privacy
public good
non-maleficence
liberty
proportionality
public good
value dignity
Guidance for Managing
Ethical Issues
in Infectious Disease
Outbreaks
WHO Library Cataloguing-in-Publication Data Guidance for managing ethical issues in infectious disease outbreaks. 1.Disease Outbreaks. 2.Communicable Diseases. 3.Ethics. I.World Health Organization. ISBN 978 92 4 154983 7 (NLM classification: WA 105) © World Health Organization 2016 All rights reserved. Publications of the World Health Organization are available on the WHO website (http://www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; email: bookorders@who.int). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (http://www.who.int/about/licensing/copyright_form/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Printed in Spain
Table of Contents
Foreword������������������������������������������������������������������������������������������������������������ 3 1
Acknowledgements������������������������������������������������������������������������������������������� 4
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
Introduction�������������������������������������������������������������������������������������������������������� 7
Guidelines��������������������������������������������������������������������������������������������������������� 12
1. Obligations of governments and the international community��������������������������� 13
2. Involving the local community��������������������������������������������������������������������������� 15
3. Situations of particular vulnerability������������������������������������������������������������������� 17
4. Allocating scarce resources�������������������������������������������������������������������������������� 20
5. Public health surveillance����������������������������������������������������������������������������������� 23
6. Restrictions on freedom of movement��������������������������������������������������������������� 25
7. Obligations related to medical interventions for the diagnosis, treatment,
and prevention of infectious disease������������������������������������������������������������������ 28
8. Research during infectious disease outbreaks����������������������������������������������������� 30
9. Emergency use of unproven interventions outside of research���������������������������� 35
10. Rapid data sharing������������������������������������������������������������������������������������������� 38
11. Long-term storage of biological specimens collected during infectious
disease outbreaks�������������������������������������������������������������������������������������������� 39
12. Addressing sex- and gender-based differences������������������������������������������������� 41
13. Frontline response workers’ rights and obligations������������������������������������������� 43
14. Ethical issues in deploying foreign humanitarian aid workers��������������������������� 47
References�������������������������������������������������������������������������������������������������������� 50
Annex 1. Ethics guidance documents consulted in developing Guidance for managing
ethical issues in infectious disease outbreaks��������������������������������������������������������������������� 52
Annex 2. Participants at meetings to formulate Guidance for managing ethical issues in
infectious disease outbreaks���������������������������������������������������������������������������������������������� 55
Foreword
Infectious disease outbreaks are periods of to see that the guidance touches upon this 3
great uncertainty. Events unfold, resources important area with advice, not only on
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
and capacities that are often limited research and emergency use of unproven
are stretched yet further, and decisions interventions, but also on rapid data sharing
for a public health response must be see: http://www.who.int/ihr/procedures/
made quickly, even though the evidence SPG_data_sharing.pdf?ua=1.
for decision‑making may be scant. In
such a situation, public health officials, The importance given to communication
policy‑makers, funders, researchers, field during an infectious disease outbreak
epidemiologists, first responders, national can make or break public health efforts,
ethics boards, health‑care workers, and public and WHO takes this very seriously. This
health practitioners need a moral compass document outlines the ethical principles that
to guide them in their decision‑making. should guide communication planning and
Bioethics puts people at the heart of the implementation at every level from frontline
problem, emphasizes the principles that workers to policy‑makers.
should guide health systems, and provides
the moral rationale for making choices, The guidance represents the work of an
particularly in a crisis. international group of stakeholders and
experts, including public health practitioners
I therefore welcome the development of in charge of response management at
the Guidance for managing ethical issues the local, national and international
in infectious disease outbreaks, which will level; nongovernmental organization
be key to embedding ethics within the representatives; directors of funding
integrated global alert and response system agencies; chairs of ethics committees; heads
for epidemics and other public health of research laboratories; representatives
emergencies. The publication will also of national regulatory agencies; patient
support and strengthen the implementation representatives; and experts in public health
and uptake of policies and programmes in ethics, bioethics, human rights, anthropology,
this context. and epidemiology. I am grateful for their
support and input.
Research is an integral part of the public
health response – not only to learn about the Dr Marie‑Paule Kieny
current epidemic but also to build an evidence Assistant Director‑General
base for future epidemics. Research during Health Systems and Innovation
an epidemic ranges from epidemiological and
socio‑behavioral to clinical trials and toxicity
studies, all of which are crucial. I am pleasedAcknowledgements
4 The Guidance document was produced University Hospitals, Switzerland; Heather
under the overall direction of Abha Saxena, Draper, University of Birmingham, United
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
Coordinator of the Global Health Ethics Kingdom; Kenneth Goodman, Miller School
team, supported by Andreas Reis and Maria of Medicine, University of Miami, USA;
Magdalena Guraiib. Morenike Oluwatoyin Ukpong, Obafemi
Awolowo University, Nigeria; Paul Bouvier,
WHO is grateful to Carl Coleman for his International Committee of the Red Cross,
role as lead writer, his analysis and synthesis Switzerland; Ruth Macklin, Albert Einstein
of existing guidance documents, and his College of Medicine, USA; Voo Tech Chuan,
incorporation of comments generated Centre for Biomedical Ethics, National
during preparatory meetings and the University of Singapore, Singapore.
broader peer review process.
The advice, comments and guidance of
Appreciation is extended to the many the following entities are also gratefully
individuals and organizations who acknowledged: COST Action IS 1201:
provided comments on drafts of the Disaster Bioethics (in particular Dónal
guidance document, including: Alice O'Mathúna, Dublin City University, Ireland;
Desclaux, Institut de Recherche pour le the staff of the Nuffield Council on
Développement, France; Aminu Yakubu, Bioethics, United Kingdom (in particular
Federal Ministry of Health, Nigeria; Annick Hugh Whittall); Johns Hopkins Berman
Antierens, Médecins Sans Frontières, Institute of Bioethics, USA (in particular
Belgium; Bagher Larijani, Endocrinology and Nancy Kass and Jeffrey Kahn); the
Metabolism Research Center, Iran (Islamic International Severe Acute Respiratory and
Republic of); Brad Freeman, Washington Emerging Infection Consortium, United
University School of Medicine, USA; Kingdom and its members (in particular
Catherine Hankins, Amsterdam Institute Alistair Nichol, Irish Critical Care–Clinical
for Global Health and Development, Research Core, University College Dublin,
Netherlands; Cheryl Macpherson, Bioethics Ireland, and Raul Pardinaz‑Solis, Centre
Department, St. George’s University School for Tropical Medicine and Global Health,
of Medicine, Grenada; Claude Vergès, University of Oxford, United Kingdom); and
Universidad de Panamá, Panama; Drue the Secretariat of the National Committee
H Barrett, Nicole J Cohen, and Rita F of Bioethics, King Abdulaziz City for
Helfand, Centers for Disease Control and Science and Technology, Kingdom of Saudi
Prevention, USA; Dirceu Greco, Federal Arabia.
University of Minas Gerais, Brazil; Edward
Foday, Ministry of Health and Sanitation, WHO appreciates the collaboration of the
Sierra Leone; Emilie Alirol, Geneva Chairperson (Christiane Woopen, thenChair of the German Ethics Council) and Both co‑chairs spent countless hours with
members of the Steering Committee of the the Secretariat and the lead writer to review
Global Summit of National Ethics/Bioethics thoughtfully the many comments received
Committees, who provided the opportunity and to give final shape to the document.
to present an earlier draft of the Guidance Philippe Calain, Médecins Sans Frontières,
to representatives of 83 national ethics Switzerland, Chair of the Ethics Panel
committees at the Summit in Berlin in and a member of various ethics working
March 2016. Their review and comments groups, continuously challenged the WHO
have been incorporated into this document. Secretariat to look beyond science to the 5
people affected by the outbreaks, their
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
The document also benefited from the cultures and their societies.
review of the Global Network of WHO
Collaborating Centers on Bioethics. Special The guidance document specifically
thanks go to Ronald Bayer, the outgoing benefited from reviews of the following
Chair of this network, and Amy Fairchild, WHO staff: Juliet Bedford, Carla Saenz
Chair of the Guideline Development Group Bresciani, Ian Clarke, Rudi J J M Coninx,
for the ethics of public health surveillance Pierre Formenty, Gaya Manori Gamhewage,
(both from Mailman School of Public Theo Grace, Paul Gully, Brooke Ronald
Health, Columbia University, USA), and to Johnson JR, Annette Kuesel, Anaïs
the incoming Chair of the network, Michael Legand, Ahmed Mohamed Amin Mandil,
Selgelid, Center for Human Bioethics, Bernadette Murgue, Tim Nguyen, Asiya
Monash University, Australia. The critical Ismail Odugleh‑Kolev, Martin Matthew
review by these individuals ensured that the Okechukwu Ota, Bruce Jay Plotkin, Annie
guidance document was consistent with Portela, Marie‑Pierre Preziosi, Manju
other ongoing projects. Rani, Nigel Campbell Rollins, Cathy Roth,
Manisha Shridhar, Rajesh Sreedharan, David
Many frontline responders and WHO staff Wood, and Yousef Elbes.
members who are routinely challenged
during epidemic outbreaks provided A special thanks to Vânia de la Fuente
valuable contributions based on their Núñez, who was responsible for managing
personal experiences; the document is the Ethics Working Group; and Michele
much richer in its content as a result. The Loi who coordinated the whole process.
WHO Research Ethics Committee and the Former interns of the Global Health
Public Health Ethics Consultative Group Ethics team Patrick Hummel (University of
provided valuable inputs, drawing especially St Andrews, United Kingdom) and Corinna
on their review of research and public Klingler (University of Munich, Germany)
health projects undertaken during the Ebola deserve a special mention for undertaking
and Zika outbreaks. a scoping review in relation to pregnancy
and infectious diseases, which informed the
WHO gratefully acknowledges the input of development of guidance in this area.
Ross Upshur, University of Toronto, Canada
(first chair of the Ethics Working Group),
and the subsequent co‑chairs Lisa Schwartz,
McMaster University, Canada, and Aissatou
Touré, Institut Pasteur de Dakar, Senegal.The guidance document would not have Health Research; Dublin City University;
been possible without the generous European Union Cooperation in Science and
support of the Wellcome Trust. The kind Technology; Monash University; University
support of the following partners is also of Miami Miller School of Medicine Institute
very gratefully acknowledged: 3U Global for Bioethics and Health Policy.
Health Partnership; Canadian Institutes of
6
Guidance for Managing Ethical Issues in Infectious Disease OutbreaksIntroduction
This guidance grew out of concern at the areas of public health, the context of 7
World Health Organization (WHO) about an outbreak has particular complexities.
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
ethical issues raised by the Ebola outbreak Decisions during an outbreak need to be
in West Africa in 2014–2016. The WHO made on an urgent basis, often in the
Global Health Ethics Unit’s response to context of scientific uncertainty, social
Ebola began in August 2014, immediately and institutional disruption, and an overall
after it was declared a “public health climate of fear and distrust. Invariably,
emergency of international concern” the countries most affected by outbreaks
pursuant to the International Health have limited resources, underdeveloped
Regulations (2005) (IHR).1 That declaration legal and regulatory structures, and
led to the formation of an Ethics Panel, and health systems that lack the resilience to
later an Ethics Working Group, which was deal with crisis situations. Countries that
charged with developing ethics guidance experience natural disasters and armed
on issues and concerns as they arose in conflicts are particularly at risk, as these
the course of the epidemic. It became circumstances simultaneously increase the
increasingly apparent that the ethical issues risk of infectious disease outbreaks while
raised by Ebola mirrored concerns that had decreasing needed resources and access to
arisen in other global infectious disease health care. Moreover, infectious disease
outbreaks, including severe acute respiratory outbreaks can generate or exacerbate
syndrome (SARS), pandemic influenza, and social crises that can weaken already fragile
multidrug‑resistant tuberculosis. However, health systems. Within such contexts, it
while WHO has issued ethical guidance is not possible to satisfy all urgent needs
on some of these outbreaks,2,3,4,5 prior simultaneously, forcing decision‑makers to
guidance has only focused on the specific weigh and prioritize potentially competing
pathogen in isolation. The purpose of this ethical values. Time pressures and resource
document is to look beyond issues specific constraints may force action without
to particular epidemic pathogens and the thorough deliberation, inclusiveness
instead focus on the cross‑cutting ethical and transparency that a robust ethical
issues that apply to infectious disease decision‑making process demands.
outbreaks generally. In addition to setting
forth general principles, it examines how This guidance document on ethical issues
these principles can be adapted to different that arise specifically in the context of
epidemiological and social circumstances. infectious disease outbreaks aims to
complement existing guidance on ethics in
While many of the ethical issues that public health. It should therefore be read
arise in infectious disease outbreaks are in conjunction with more general guidance
the same as those that arise in other on issues such as public health surveillance,research with human participants, and cases alike, avoiding discrimination and
addressing the needs of vulnerable exploitation, and being sensitive to persons
populations. who are especially vulnerable to harm or
injustice. The second aspect of justice is
Setting up decision‑making systems procedural justice, which refers to a fair
and procedures in advance is the best process for making important decisions.
way to ensure that ethically appropriate Elements of procedural justice include due
decisions will be made if an outbreak process (providing notice to interested
8 occurs. Countries, health‑care institutions, persons and an opportunity to be heard),
international organizations and others transparency (providing clear and accurate
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
involved in epidemic response efforts are information about the basis for decisions
encouraged to develop practical strategies and the process by which they are made),
and tools to apply the principles in this inclusiveness/community engagement
guidance document to their specific (ensuring all relevant stakeholders are able
settings, taking into account local social, to participate in decisions), accountability
cultural, and political contexts. WHO is (allocating and enforcing responsibility
committed to providing countries with for decisions), and oversight (ensuring
technical assistance in support of these appropriate mechanisms for monitoring
efforts. and review).
Beneficence — Beneficence refers to acts
Relevant ethical principles that are done for the benefit of others,
such as efforts to relieve individuals’ pain
Ethics involves judgements about “the and suffering. In the public health context,
way we ought to live our lives, including the principle of beneficence underlies
our actions, intentions, and our habitual society’s obligation to meet the basic needs
behaviour.”3 The process of ethical analysis of individuals and communities, particularly
involves identifying relevant principles, humanitarian needs such as nourishment,
applying them to a particular situation, shelter, good health, and security.
and making judgements about how to
weigh competing principles when it is not Utility — The principle of utility states
possible to satisfy them all. This guidance that actions are right insofar as they
document draws on a variety of ethical promote the well‑being of individuals or
principles, which are grouped below into communities. Efforts to maximize utility
seven general categories. These categories require consideration of proportionality
are presented merely for the convenience (balancing the potential benefits of an
of the reader; other ways of grouping them activity against any risks of harm) and
are equally legitimate. efficiency (achieving the greatest benefits at
the lowest possible cost).
Justice — As used in this document,
justice, or fairness, encompasses two Respect for persons — The term “respect
different concepts. The first is equity, for persons” refers to treating individuals
which refers to fairness in the distribution in ways that are fitting to and informed by
of resources, opportunities and outcomes. a recognition of our common humanity,
Key elements of equity include treating like dignity and inherent rights. A centralaspect of respect for persons is respect for of minorities and groups that suffer from
autonomy, which requires letting individuals discrimination.
make their own choices based on their
values and preferences. Informed consent,
a process in which a competent individual Practical applications
authorizes a course of action based on
sufficient relevant information, without The application of ethical principles should
coercion or undue inducement, is one be informed by evidence as far as it is
way to operationalize this concept. Where available. For example, in determining 9
individuals lack decision‑making capacity, it whether a particular action contributes to
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
may be necessary for others to be charged utility, decision‑makers should be guided
with protecting their interests. Respect for by any available scientific evidence about
persons also includes paying attention to the action’s expected benefits and harms.
values such as privacy and confidentiality, as The more intrusive the proposed action, the
well as social, religious and cultural beliefs greater the need for robust evidence that
and important relationships, including what is being proposed is likely to achieve
family bonds. Finally, respect for persons its desired aim. When specific evidence is
requires transparency and truth‑telling in not available, decisions should be based
the context of carrying out public health on reasoned, substantive arguments and
and research activities. informed by evidence from analogous
situations, to the extent possible.
Liberty — Liberty includes a broad range
of social, religious and political freedoms, In balancing competing principles during
such as freedom of movement, freedom of infectious disease outbreaks, countries
peaceful assembly, and freedom of speech. must respect their obligations under
Many aspects of liberty are protected as international human rights agreements. The
fundamental human rights. Siracusa Principles on the Limitation and
Derogation Provisions in the International
Reciprocity — Reciprocity consists of Covenant on Civil and Political Rights
making a “fitting and proportional return” (the “Siracusa Principles”)8 are a widely
for contributions that people have made.6 accepted framework for evaluating
Policies that encourage reciprocity can the appropriateness of limiting certain
be an important means of promoting the fundamental human rights in emergency
principle of justice, as they can correct situations. The Siracusa Principles provide
unfair disparities in the distribution of the that any restrictions on human rights must
benefits and burdens of epidemic response be carried out in accordance with the law
efforts. and in pursuit of a legitimate objective of
general interest. In addition, such restrictions
Solidarity — Solidarity is a social relation must be strictly necessary and there must
in which a group, community, nation be no other, less intrusive means available
or, potentially, global community stands to reach the same objective. Finally, any
together.7 The principle of solidarity justifies restrictions must be based on scientific
collective action in the face of common evidence and not imposed in an arbitrary,
threats. It also supports efforts to overcome unreasonable, or discriminatory manner.
inequalities that undermine the welfareFor both pragmatic and ethical reasons, guidance that could be tailored to
maintaining the population’s trust in different epidemiological, social, and
epidemic response efforts is of fundamental economic contexts. They also discussed
importance. This is possible only if the importance of focusing on broader
policy‑makers and response workers act questions of global health governance,
in a trustworthy manner by applying community engagement, knowledge
procedural principles fairly and consistently, generation, and priority setting. Finally,
being open to review based on new participants emphasized the urgent need to
10 relevant information, and acting with the develop concrete operational tools to help
genuine input of affected communities. individuals involved in epidemic response
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
In addition, a synchronized approach efforts to incorporate ethical guidance into
is indispensable to the success of any practical decision‑making. The group met
response effort. All members of the global again in November 2015 in Prato, Italy
community need to act in solidarity, since to review an initial draft of the guidance
all countries share a common vulnerability and to hear from additional experts and
to the threat of infectious disease. stakeholders, including survivors of the
recent Ebola outbreak. Following this
meeting, a new draft was developed and
How the Guidance circulated for international peer review. The
was developed experts that participated in these meetings
to prepare the Guidelines are listed in
Many individuals have helped shape this Annex 2.
guidance document, directly or indirectly,
starting with the Ethics Panel that was This document is organized around
convened by the Director‑General on 14 specific guidelines, each of which
11 August 2014, and the ad‑hoc ethics addresses key aspects of epidemic
working groups that met in Geneva, planning and response. Each guideline is
Switzerland between August and October introduced by a series of questions that
2014 to provide guidance on the use of illustrate the scope of the ethical issues,
untested interventions during the Ebola followed by a more detailed discussion that
outbreak in West Africa. Subsequently, articulates the rights and obligations of
in May 2015, a group of experts and relevant stakeholders. It is hoped that this
stakeholders met in Dublin, Ireland document will be useful to policy‑makers,
to review existing ethical statements public health professionals, health‑care
on infectious disease outbreaks and providers, frontline responders, researchers,
develop a methodology to create a more pharmaceutical and medical device
comprehensive document. To assist this companies, and other relevant entities
process, an analysis and synthesis of all involved in infectious disease outbreaks
existing guidance documents relevant planning and response efforts in the public
to ethical considerations in infectious and private sectors.
disease outbreaks was prepared
(Annex 1). Reflecting on lessons learnt
from previous outbreaks, particularly
the recent experiences with Ebola,
participants emphasized the need forSource: WHO
Ebola in DRC
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
11Guidelines
1. Obligations of governments
and the international community
13
Questions addressed:
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
• What are the obligations of governments to prevent and respond to infectious
disease outbreaks?
• Why do countries’ obligations to prevent and respond to infectious disease
outbreaks extend beyond their own borders?
• What obligations do countries have to participate in global surveillance and
preparedness efforts?
• What obligations do governments have to provide financial, technical, and
scientific assistance to countries in need?
Governments can play a critical role in Economic, Social and Cultural Rights has
preventing and responding to infectious recognized, “given that some diseases are
disease outbreaks by improving social easily transmissible beyond the frontiers
and environmental conditions, ensuring of a State, the international community
well‑functioning and accessible health has a collective responsibility to address
systems, and engaging in public health this problem. The economically developed
surveillance and prevention activities. States Parties have a special responsibility
Together, these actions can substantially and interest to assist the poorer developing
reduce the spread of diseases with epidemic States in this regard.”9
potential. In addition, they help assure that
an effective public health response will be These obligations reflect the practical
possible if an epidemic occurs. Governments reality that infectious disease outbreaks do
have an ethical obligation to ensure the not respect national borders, and that an
long‑term capacity of the systems necessary outbreak in one country can put the rest of
to carry out effective epidemic prevention the world at risk.
and response efforts.
Countries’ obligations to consider the
Countries have obligations not only to needs of the international community do
persons within their own borders but also not arise solely in times of emergency.
to the broader international community. Instead, they require ongoing attention to
As the United Nations Committee on ameliorate the social determinants of poorhealth that contribute to infectious disease preparedness plans for infectious
outbreaks, including poverty, limited access disease outbreaks and other potential
to education, and inadequate systems of disasters and provide guidance to
water and sanitation. relevant health‑care facilities to
implement the plans.
The following are key elements of the
obligations of governments and the • Providing financial, technical, and
international community: scientific assistance — Countries
14 that have the resources to provide
• Ensuring the sufficiency of national foreign assistance should support
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
public health laws — As discussed global epidemic preparedness and
later in this document, certain public response efforts, including research
health interventions that might be and development on diagnostics,
necessary during an infectious disease therapeutics, and vaccines for
outbreak (e.g. restrictions on freedom pathogens with epidemic potential. This
of movement) depend on having a clear support should supplement ongoing
legal basis for government action, as efforts to build local public health
well as a system in place to provide capacities and strengthen primary
oversight and review. All countries health care systems in countries at
should review their public health laws to greatest risk of harm from infectious
ensure that they give the government disease outbreaks.
sufficient authority to respond
effectively to an epidemic while also
providing individuals with appropriate
human rights protections.
• Participating in global surveillance
and preparedness efforts —
All countries must carry out their
responsibilities under the IHR to
participate in global surveillance
efforts in a truthful and transparent
manner. This includes providing
prompt notification of events that may
constitute a public health emergency
of international concern, regardless
of any negative consequences that
may be associated with notification,
such as a possible reduction in trade
or tourism. The obligation to provide
prompt notification to the international
community stems not only from the
text of the IHR but also from the ethical
principles of solidarity and reciprocity. Avian Influenza in Indonesia
Source: Gary Hampton, WHO
In addition, countries should develop2. Involving the local community
15
Questions addressed:
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
• Why is community engagement a critical component of infectious disease
outbreak response efforts?
• What are the hallmarks of a community‑centred approach to infectious disease
outbreak response?
• What should decision‑makers do with input they receive during community
engagement activities?
• What is the media’s role in infectious disease outbreak response efforts?
All aspects of infectious disease outbreak public communication with health
response efforts should be supported authorities.
by early and ongoing engagement with
the affected communities. In addition to • Situations of particular
being ethically important in its own right, vulnerability — As discussed further
community engagement is essential to in Guideline 3, special attention should
establishing and maintaining trust and be given to ensuring that persons who
preserving social order. face heightened susceptibility to harm
or injustice during infectious disease
Involving communities fully in infectious outbreaks are able to contribute to
disease outbreak planning and response decisions about infectious disease
efforts requires attention to the following outbreak planning and response. Public
issues: health officials should recognize that
such persons might be distrustful of
• Inclusiveness — All persons who government and other institutions, and
could potentially be affected should make special efforts to include them in
have opportunities to make their community engagement plans.
voices heard in all stages of infectious
disease outbreak planning and • Openness to diverse perspectives —
response, either directly or through Communication efforts should be
legitimate representatives. Adequate designed to facilitate a genuine
communication platforms and tools two-way dialogue, rather than as
should be put in place to facilitate merely a means to announce decisionsthat have already been made. and implementing decisions in relation
Decision‑makers should be prepared to the outbreak response, and how they
to recognize and debate alternative can challenge decisions they believe are
approaches and revise their decisions inappropriate.
based on information they receive.
Reaching out to the community early, The media will play an important role in
and allowing for consideration of any infectious disease outbreak response
the interests of all people who will effort. It is therefore important to ensure
16 potentially be affected, can play an that the media has access to accurate
important role in building trust and and timely information about the disease
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
empowering communities to be and its management. Governments,
involved in a genuine dialogue. nongovernmental organizations, and
academic institutions should make efforts to
• Transparency — The ethical support media training in relevant scientific
principle of transparency requires that concepts and techniques for communicating
decision‑makers publicly explain the risk information without raising unnecessary
basis for decisions in language that is alarm. Media training is important for public
linguistically and culturally appropriate. health sector employees who may interact
When decisions must be made in with media covering public health issues.
the face of uncertain information, In turn, the media has a responsibility to
the uncertainties should be explicitly provide accurate, factual, and balanced
acknowledged and conveyed to the reporting. This is an important component
public. of media ethics.
• Accountability — The public should
know who is responsible for making
Cholera outbreak in Sierra Leone
Source: Fid Thompson3. Situations of particular vulnerability
17
Questions addressed:
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
• Why are some individuals and groups considered particularly vulnerable during
infectious disease outbreaks?
• How can vulnerability affect a person’s ability to access services during infectious
disease outbreaks?
• How can vulnerability affect a person’s willingness and ability to share and receive
information during an infectious disease outbreak?
• Why are stigmatization and discrimination particular risks during infectious disease
outbreaks?
• In what ways might vulnerable persons suffer disproportionate burdens from
infectious disease response efforts, or have a greater need for resources?
Some individuals and groups face • Difficulty accessing services
heightened susceptibility to harm or and resources — Many of the
injustice during infectious disease characteristics that contribute to social
outbreaks. Policy-makers and epidemic vulnerability can make it difficult
responders should develop plans to for individuals to access necessary
address the needs of such individuals and services. For example, persons with
groups in advance of an outbreak and, physical disabilities may have mobility
if an outbreak occurs, make reasonable impairments that make travelling even
efforts to ensure that these needs are short distances difficult or impossible.
actually met. Doing this requires ongoing Other socially vulnerable persons
attention to community engagement and may lack access to safe and reliable
the development of active social networks transportation or have caregiving
between community representatives and responsibilities that make it difficult for
government actors. them to leave their homes. In addition,
vulnerable persons may lack access
Efforts to address the ways in which to necessary resources such as clean
individuals and groups may be vulnerable water or bednets to reduce the risk of
should take into account the following: contracting a mosquito-borne disease.• Need for effective alternative are designed with the best of
communication strategies — Some intentions, they can inadvertently place
types of vulnerability can impede a disproportionate burden on particular
an individual’s ability to transmit or populations. For example, quarantine
receive information. Communication orders that require individuals to stay
barriers can stem from a wide range in their homes can have devastating
of factors including, but not limited consequences for persons who need
to, illiteracy, unfamiliarity with the to leave their homes to obtain basic
18 local or official language(s), vision or necessities such as clean water or food.
hearing impairments, social isolation, Similarly, social distancing measures
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
or lack of access to Internet and other such as school closures can place
communication services. These barriers disproportionate burdens on children
make it difficult for individuals to receive who depend on going to school to
necessary public health messages access regular meals, as well as on
or to participate fully in community working parents who may have no one
engagement activities. To overcome available to provide child care.
these barriers, messages should be
delivered in multiple formats (e.g. radio, • Greater need for resources —
text messages, billboards, cartoons) as Accommodating the needs of
well as direct oral communication with individuals whose situation makes
key stakeholders. Health authorities them particularly vulnerable sometimes
should not assume that the public will requires the use of additional resources.
search for information; instead, they In some cases, additional resources
should proactively reach out to the are relatively minimal, such as when
concerned population wherever they an interpreter is hired to make
are. a community engagement forum
accessible to members of a linguistic
• Impact of stigmatization and minority group. In other cases, they
discrimination — Members of socially may be more substantial, such as when
disadvantaged groups often face mobile health teams are assembled to
considerable stigma and discrimination, dispatch vaccines and treatments to
which can be exacerbated in public hard-to-reach rural areas. It is legitimate
health emergencies characterized by to take costs into consideration in
fear and distrust. Those responsible for determining whether a particular
infectious disease outbreak response accommodation is warranted; indeed,
should ensure that all individuals are the goal of maximizing utility demands
treated fairly and equitably regardless of that such assessments be made.
their social status or perceived “worth” However, despite the importance of
to society. They should also take conserving limited resources, the ethical
measures to prevent stigmatization and principle of equity may sometimes
social violence. justify providing greater resources to
persons who have greater needs.
• Disproportionate burdens of
outbreak response measures — • Heightened risk of violence —
Even when public health measures Infectious disease outbreaks canexacerbate social unrest, increase specific populations may be targeted
criminality, and induce violent as being the cause of the outbreak
behaviour, especially against vulnerable or provoking transmission; strategies
groups such as minority populations should be proactively designed to
or migrants. In addition, public health protect members of such groups from
measures such as home isolation, a heightened risk of violence.
quarantine, or closure of schools and
work facilities can induce violence,
particularly against women and 19
children. Officials involved in outbreak
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
planning and response efforts should
be prepared for the possibility that
A doctor inspects patients in an
MSF supported hospital in Aweil,
Northern Bar El Ghazal in South Sudan, 2011
Source: Siegfried Modola/IRIN4. Allocating scarce resources
20
Questions addressed:
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
• What type of resource allocation decisions might need to be made during
infectious disease outbreaks?
• How do the principles of utility and equity apply to decisions about allocating
scarce resources during infectious disease outbreaks?
• How does the principle of reciprocity apply to decisions about allocating scarce
resources during infectious disease outbreaks?
• What procedural considerations apply to decisions about resource allocation
during infectious disease outbreaks?
• What obligations do health-care providers have towards persons who are not able
to access life-saving resources during infectious disease outbreaks?
Infectious disease outbreaks can quickly sanitation facilities or building quarantine
overwhelm the capacities of governments facilities?
and health-care systems, requiring them
to make difficult decisions about the Infectious disease outbreaks also compete
allocation of limited resources. Some of with other important public health
these decisions may arise in the context of issues for attention and resources. For
allocating medical interventions, such as example, one of the consequences of
hospital beds, medications, and medical the Ebola outbreak was a reduction in
equipment. Others may relate to broader access to general health-care services
questions about how public health due to a combination of a greater
resources should be utilized. For example, number of patients and the sickness
how should limited resources be allocated and death of health-care workers. As
between activities such as surveillance, a result, deaths from tuberculosis, human
health promotion, and community immunodeficiency virus (HIV), and malaria
engagement? Should human resources be increased dramatically during this period.10
devoted to contact tracing at the possible
expense of patient management? Should Governments, health-care facilities, and
limited funds be spent improving water and others involved in response efforts shouldprepare for such situations by developing • Defining utility on the basis of
guidelines on the allocation of scarce health-related considerations —
resources in outbreak situations. Such In order to apply the ethical principle
guidelines should be developed through of utility, it is first necessary to identify
an open and transparent process involving the type of outcomes that will be
broad stakeholder input and, to the extent counted as improvements to welfare.
possible, should be incorporated into formal In general, the focus should be on the
written documents that establish clear health-related benefits of allocation
priorities and procedures. Those involved mechanisms, whether defined in terms 21
in developing these guidelines should be of the total number of lives saved, the
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
guided by the following considerations: total number of life years saved, or
the total number of quality-adjusted
• Balancing considerations of utility life years saved. For this reason,
and equity — Resource allocation while it might be ethical to prioritize
decisions should be guided by the persons who are essential to manage
ethical principles of utility and equity. an outbreak, it is not appropriate to
The principle of utility requires prioritize persons based on social value
allocating resources to maximize considerations unrelated to carrying out
benefits and minimize burdens, while critical services necessary for society.
the principle of equity requires attention
to the fair distribution of benefits • Paying attention to the needs of
and burdens. In some cases, an equal vulnerable populations — In applying
distribution of benefits and burdens the ethical principle of equity, special
may be considered fair, but in others, attention should be given to individuals
it may be fairer to give preference to and groups that are the most vulnerable
groups that are worse off, such as the to discrimination, stigmatization, or
poor, the sick, or the vulnerable. It is isolation, as discussed in Guideline 3.
not always be possible to achieve fully Particular consideration must be
both utility and equity. For example, given to individuals who are confined
establishing treatment centres in large in institutional settings, where they
urban settings promotes the value of are highly dependent on others and
utility because it makes it possible to potentially exposed to much higher risks
treat a large number of people with of infection than persons living in the
relatively few resources. However, such community.
an approach may be in tension with the
principle of equity if it means that fewer • Fulfilling reciprocity-based
resources will be directed to isolated obligations to those who contribute
communities in remote rural areas. to infectious disease outbreak
There is no single correct way to resolve response efforts — The ethical
potential tensions between utility principle of reciprocity implies that
and equity; what is important is that society should support persons who
decisions are made through an inclusive face a disproportionate burden or risk
and transparent process that takes into in protecting the public good. This
account local circumstances. principle justifies giving priority access
to scarce resources to persons whoassume risks to their own health or • Avoiding corruption — Corruption
life to contribute to outbreak response in the health-care sector may be
efforts. exacerbated during infectious
disease outbreaks if large numbers of
• Providing supportive and palliative individuals are competing for access
care to persons unable to access life- to limited resources. Efforts should be
saving resources — Even when it is not made to ensure that persons involved in
possible to provide life-saving medical the application of allocation systems do
22 resources to all who could benefit from not accept or give bribes or engage in
them, efforts should be made to ensure other corrupt activities.
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
that no patients are abandoned. One
way to do this is to ensure that adequate • Separation of responsibilities —
resources are directed to providing To the extent possible, the
supportive and palliative care. interpretation of allocation principles
should not be entrusted to clinicians
The application of allocation principles who have pre-existing professional
should take into account the following relationships that create an ethical
considerations: obligation to advocate for the
interests of specific patients or groups.
• Consistent application — Allocation Instead, decisions should be made
principles should be applied in by appropriately qualified clinicians
a consistent manner, both within who have no personal or professional
individual institutions and, to the reasons to advocate for one patient or
extent possible, across geographic group over another.
areas. Decision-making tools should
be developed to ensure that like cases
are treated alike, and that no person
receives better or worse treatment
due to his or her social status or other
factors not explicitly recognized in
the allocation plan. Efforts should be
made to avoid unintended systemic
discrimination in the choice or
application of allocation methods.
• Resolution of disputes —
Mechanisms should be developed
to resolve disagreements about the
application of allocation principles;
these mechanisms should be designed
to ensure that anyone who believes that
allocation principles have been applied
inappropriately has access to impartial
and accountable review processes, and
has the opportunity to be heard.5. Public health surveillance
23
Questions addressed:
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
• What role does surveillance play in infectious disease outbreak response efforts?
• Should surveillance activities be subject to ethical review?
• What obligations do entities conducting surveillance activities have to protect the
confidentiality of information collected?
• Are there any circumstances under which individuals should be asked for consent
to, or given the opportunity to opt out of, surveillance activities?
• What obligations do those conducting surveillance activities have to disclose
information they collect to the affected individuals and communities?
Systematic observation and data collection health activities should be consistent with
are essential components of emergency accepted norms of public health ethics and
response measures, both to guide the conducted by individuals or entities that
management of the current outbreak and can be held accountable for their decisions.
to help prevent and respond to outbreaks
in the future. Even if these activities are Ensuring high-quality, ethically appropriate
not characterized as research for regulatory surveillance is complicated by at least
purposes, an ethical analysis should two factors. First, the law surrounding
be undertaken to ensure that personal surveillance across jurisdictions may be
information is protected from physical, unnecessarily complex or inconsistent.
legal, psychological, and other harm. Second, surveillance activities will occur
Countries should consider organizing across jurisdictions with varying levels
systems for ethical oversight of public of resources, thus placing strains on the
health activities, commensurate with the quality and reliability of the data. These
activity objectives, methods, risks and issues are likely to be exacerbated during
benefits, as well as the extent to which the an infectious disease outbreak, creating
activity involves individuals or groups whose an urgent need for careful planning and
situation may make them vulnerable. international collaboration. Specific issues
Regardless of whether such systems that should be addressed include the
are adopted, ethical analysis of public following:• Protecting the confidentiality would undermine the activity’s public
of personal information — The health goals.
unauthorized disclosure of personal
information collected during an • Disclosing information to
infectious disease outbreak (including individuals and communities —
name, address, diagnosis, family Regardless of whether individuals
history, etc.) can expose individuals are given the choice to opt out of
to significant risk. Countries should surveillance activities, the process of
24 ensure that adequate protection exists surveillance should be conducted on
against these risks, including laws a transparent basis. At a minimum,
Guidance for Managing Ethical Issues in Infectious Disease Outbreaks
that safeguard the confidentiality individuals and communities should
of information generated through be aware of the type of information
surveillance activities, and that strictly that will be gathered about them, the
limit the circumstances in which such purposes for which this information will
information may be used or disclosed be used, and any circumstances under
for purposes different from those for which the information collected may be
which it was initially collected. Use and shared with third parties. In addition,
sharing of non-aggregated surveillance information about the outcome of the
data for research purposes must have surveillance activity should be made
the approval of a properly constituted available as soon as reasonably possible.
and trained research ethics committee. Careful attention should be given to
the manner in which this information
• Assessing the importance of is communicated, in order to minimize
universal participation — Public the risk that subjects of surveillance may
health surveillance is typically conducted face stigmatization or discrimination.
on a mandatory basis, without
the possibility of individual refusal.
Collecting surveillance information
on a mandatory basis is ethically
appropriate on the grounds of public
interest if an accountable governmental
authority has determined that universal
participation is necessary to achieve
compelling public health objectives.
However, it should not be assumed
that surveillance activities must always
be carried out on a mandatory basis.
Entities responsible for designing and
approving surveillance programmes
should consider the appropriateness
of allowing individuals to opt out of
particular surveillance activities, taking
into account the nature and degree
of individual risks involved and the
extent to which allowing opt-outsYou can also read
