.Ethical questions related to health, health care, and pub- lic health cover topics as diverse as moral issues around reproduction, state obligations in the provision of health care services, and appropriate measures to control infec- tious disease. Scholars and health care professionals have debated ethical questions related to health and health care since the earliest days of medicine. Recent formal efforts to articulate international standards of ethics applicable to health and health care can be traced to the Nuremberg trials of 1947, during which the horrors of Nazi medical experiments came to light. The principles that emerged from those trials, known as the Nuremberg Code1, are broadly applicable to many types of health-related research involving human participants, including clinical trials. The growing breadth and complexity of contemporary health challenges have produced a range of difficult questions that cannot always be adequately addressed by relying exclusively on existing policies, guidelines or codes of con- duct. Debates over access to new and expensive pharma- ceuticals and medical technologies, as well as increasing awareness of the gross health disparities that exist both within and between countries, have called attention to the need for an ethics of health policy and practice.In the face of limited resources and competing priorities, health care service providers, biomedical and public health investigators, and policy-makers are often forced to make difficult choices about how best to secure optimal healthoutcomes for individuals and populations. Demands for rapid action may leave little time for adequate consideration of ethical issues. However, a failure to give explicit atten- tion to ethics may result in various wrongs, such as harm and injustice, the consequences of which are often borne disproportionately by the most vulnerable groups. Thus, it is critical that ethics remains central to decision-making in health and health care.This document aims to assist policy-makers, health care providers and researchers to understand key concepts in health ethics and to identify basic ethical questions sur- rounding health and health care. It illustrates the chal- lenges of applying ethical principles to global public health and outlines practical strategies for dealing with those chal- lenges. The document is divided into four main parts. The first part explores key concepts in health ethics and explains common terms, theories and principles. The second part examines the main challenges in the practice of health ethics from the perspective of global public health. These issues provide the reader with a concrete understanding of the various ethical obstacles that may arise in public health, health research, and the provision of health care services. The third part describes practical strategies for dealing with these challenges and the key actors involved in developing ethical frameworks. Finally, the fourth part explains why health ethics is important to WHO, and how WHO sup- ports Member States in building capacity in health ethics.Introduction
Introduction7 
A. Introduction to health ethics: key concepts
A. Introduction to health ethics: key concepts9
1. What is health ethics?Ethics, derived from the Greek ethos, or “behaviour”, is concerned with questions about right versus wrong con- duct and what constitutes a good or bad life, as well as the justificatory basis for such questions, the situations in which values conflict (e.g. ethical dilemmas), and the sys- tematic analysis and resolution of these conflicts. Health ethics is the interdisciplinary field of study and practice that seeks specifically to understand the values undergird- ing decisions and actions in health care, health research and health policy, and to provide guidance for action when these values conflict. It is distinguishable from the narrower medical ethics, which is concerned with ethical issues that arise in the clinical context related to the care of specific patients, as well as the broader bioethics, which refers to ethical issues arising from the creation and maintenance of the health of all living things.2Health ethics has a broad focus, taking in ethical issues faced by health professionals, health policy-makers and health researchers, as well as by patients, families, and communities in a range of contexts related to health, including clinical care, health services and systems, public health, epidemiology, information technology and the use of animals in research. Health ethics is built on a sound appreciation of the empirical realities of particular health issues. For example, if authorities have a limited supply of vaccine, an ethical analysis of the situation is likely to take into account clinical concerns about vaccine side-effects, epidemiological concerns about herd immunity and pop- ulation risk, and logistic concerns about maintaining an effective and efficient delivery system. What health ethics adds to the analysis is the incorporation of value-oriented questions, such as the equity of the vaccine distribution system and its impact on vulnerable groups. Health eth- ics is increasingly on the curriculum in health professional and bioscience training, as well as programmes in health administration, health economics, public health, law, bio- technology (e.g. genomics) and environmental health. Though it is a comparatively young field, there is an exten- sive and growing international literature in the area, and many research efforts are devoted to understanding it.2. What is the difference between ethical, social and personal values in health?If ethics is concerned with the values underlying deci- sions and action, what values and whose values are rel- evant? Values describe what is important to an individual, a group, or a society. Values that are commonly invokedinclude autonomy, fairness, equity, compassion, honesty, freedom, solidarity, trust and respect. Some of these values might be specified as principles, e.g. “health inequities in a population ought to be minimized” or “patients should give free and informed consent to treatment”, in which case they provide guidance for concrete decisions and actions. Sometimes a situation may give rise to a conflict between different values, such as when achieving greater equity may involve some reduction in individual autonomy, or between values at the universal, group, or individual levels. Moreover, different societies may have different val- ues and practices. Most people would agree that tolerance of such differences is important, and we must, generally, respect values that differ from our own. However, it is also important to realize that not all personal or societal values have equivalent moral status. For example, slavery violates ideas of equal respect for all human beings. Even if an indi- vidual or group wishes to support slavery, others in society are not bound to respect such a view. Where apparent dis- agreement exists, it is worth taking time to understand and discuss divergent points of view. Often, a resolution can be found, but sometimes respectful disagreement will be the only option.3. What is the relationship between health ethics and the law?Both ethics and law are normative frameworks, i.e. they define how people ought to act. Ethics and law are often complementary; for example, a legal decree might require a person to do what is ethically required (such as refrain from harming others). However, something can be legal and yet conflict with ethical standards. For instance, there are no laws prohibiting countries from investing vast pub- lic resources in the development of medical interventions of minor public health significance, such as a cure for male-pattern baldness. But one might wonder whether, ethically speaking, countries should not instead devote their resources to reducing the burden of life-threatening disease. Similarly, ethics is concerned with a broader set of relationships and behaviours than most forms of legal regulation. For example, speaking disrespectfully to one’s parents may be considered unethical, even though it is not against the law. It is also possible that individual laws may themselves violate important ethical principles, e.g. laws that discriminate against certain groups in a population. Ethical analysis of the law can stimulate important reform efforts or acts of civil disobedience.Even when ethics and law are consistent, important dif- ferences between the fields remain. For example, laws
10A. Introduction to health ethics: key concepts
Judges of Military Tribunal No. 1, Nuremberg, Germany, 1946–1947.Source: United States National Archives and Records Administration.sometimes provide general standards, the interpretation of which requires further ethical analysis, e.g. a law pro- hibiting public health authorities from imposing “unrea- sonable” restrictions on individual liberty. In addition, the violation of an ethical norm entails different sanctions than the breaking of a legal code. In the former case, the viola- tor might suffer rejection and disapproval by society; in the latter, a concrete punishment, such as a fine or imprison- ment, might be imposed. In sum, while ethics and law are different in certain ways, ethics remains a foundation for law, and often provides a justificatory basis for legal norms.4. What is the relationship between health ethics and human rights?Human rights are “those rights which are inherent to the human being.”3 The modern human rights movement developed after the Second World War and the adoption of the Universal Declaration of Human Rights in 1948,4 and led to the adoption of treaties and other sources of law “protecting individuals and groups against actions which interfere with fundamental freedoms and human dignity”. Human rights encompass what are known as civil, cultural, economic, political and social rights. Gov- ernments have an affirmative obligation to respect, pro- tect, and fulfil human rights. The obligation to respect human rights means that government must not interfere, directly or indirectly, with individuals’ enjoyment of humanrights. The obligation to protect human rights means that government has a duty to prevent third parties from inter- fering with individuals’ enjoyment of human rights. And the obligation to fulfil human rights requires government to adopt appropriate legal, budgetary, and other measures to ensure that individuals’ human rights are fully realized.5Ethical questions about the duties and responsibilities of individuals and institutions include questions about the actions required to ensure the protection and promotion of human rights. Additional ethical questions related to human rights include questions about what should be done in cases where there is a conflict between different human rights, such as when protecting the community’s right to health may require limiting the liberty of people with con- tagious disease. In addition, when limited resources make it impossible to satisfy everyone’s human right to health care, ethical analysis is necessary to establish priorities. While concerns about ethics and human rights are closely related—human rights, after all, are ultimately grounded in overarching ethical principles, such as liberty and equal- ity—there are also important distinctions between the two. What human beings have a right to as a matter of ethics is not necessarily the same as what they have a right to as a matter of law. It might be argued that there are human rights that people should have that have not yet been enshrined in legally binding human rights instruments.
A. Introduction to health ethics: key concepts11 
B. Health ethics in practice: key issues and challenges
B. Health ethics in practice : key issues and challenges 13
5. What are key ethical issues in public health?Both public health practice and policy raise diverse ethi- cal considerations. An important set of issues concerns the relationship between the liberty of the individual and broader societal concerns. Other important issues include such things as equity, solidarity, social justice, reciprocity, and trust. Underlying all approaches to public health ethics is a strong commitment to collective action as a means of protecting individuals and the public from harm and pro- moting the highest attainable standard of health.Harm prevention, public good and individual libertyIndividuals have a right to privacy and to freedom of move- ment. However, because infectious disease threatens the health and welfare of others, it may be legitimate to restrict people’s privacy and liberty in order to protect others in the community. How far may governments go in limiting privacy and freedom of movement in the name of infec- tious disease control? With the outbreak of severe acute respiratory syndrome (SARS) in 2002–2003, health officials in both Asia and North America relied on strategies such as closing schools, cancelling social gatherings, and quar- antining people suspected of being infected. In retrospect, it became clear that some of these strategies were more extensive than necessary to address the public health crisis. Yet, where outcomes are uncertain and potentially cata- strophic, liberty-restricting actions may well be justified by values such as solidarity and reciprocity, provided that the restrictions are informed by evidence, proportionate to the threat (see “Proportionality” in the glossary of terms), car- ried out humanely and limited to the immediate crisis at hand (see Siracusa Principles in Human Rights).6Treatment and preventionMuch public health practice and policy is founded on the idea that prevention is better than waiting for harm to develop and then focusing on treatment. The argument in favour of prevention can be a financial one (it is cheaper), a practi- cal one (when prevention is possible, why wait to intervene until the disease actually develops?) or a moral one (a focus on prevention may reduce overall suffering). At the same time, when resources are limited, devoting greater atten- tion to prevention may take away needed resources from treatment. Determining how to allocate scarce resources between prevention and treatment can therefore raise dif- ficult ethical issues related to distributive justice.For example, scientists working in disease prevention have recently determined that providing antiretroviral therapy to people infected with HIV may significantly lower the risk that they will transmit the virus to uninfected sexual and needle-sharing partners. However, this approach may lead to the use of antiretroviral therapy in persons who do not need it for their own clinical benefit. Should the provision of antiretroviral therapy to those who would get sicker or even die without it take priority over the provision of medi- cation for the purpose of reducing the risk of transmis- sion? What are the global obligations to meet the needs of nations facing these difficult trade-offs?Health promotion and equityIll-health related to chronic disease is rising across the world. A large part of this disease burden is caused by so-called lifestyle choices, such as smoking tobacco, drink- ing alcohol, overeating, and not exercising enough. What ethical obligations do governments have to try to change such behaviour? For example, we know that smoking is harmful and linked to the death and suffering of millions of people each year. It is also a deeply entrenched, often addictive, behaviour. At the same time, autonomous adults generally have the right to engage in risky behaviour, as long as their actions do not put other people directly at risk. In this context, to what extent do governments have an ethical obligation to adopt policies that reduce the harm resulting from smoking? Should governments use the tax system to deter individuals from starting or continuing to smoke? Is it acceptable to place limits on the advertising ofWHO provides vaccinations against diphtheria and tetanus at Port-au-Prince’s National Stadium, where many Haitians displaced by the earthquake have set up temporary shelters.
Source: UN Photo/Sophia Paris.
14B. Health ethics in practice : key issues and challenges
A health worker performs an antenatal examination on Mema Kiahon in the maternal and child health section of the UNICEF- supported clinic in Senjeh, a town in Cape Mount County, Liberia. Source: UNICEF/Giacomo Pirozzi.tobacco products? Is it appropriate for governments to seek to influence the cultural and social factors that may lead some people to take up smoking? Similar issues arise in other contexts, such as the use of alcohol and the excessive consumption of unhealthy foods.Public health surveillancePublic health activity requires robust data on the level of disease and threats to health within a population. Such data allow threats to individual and population health to be assessed, and priorities set and resources allocated on the basis of risk. How should the need for accurate disease sur- veillance data be balanced against the principle of individual autonomy? For example, in the mid-1980s, blood samples that had been taken for clinical purposes were stripped of identifying information and tested for HIV, in an attempt to estimate the prevalence of HIV infection in the popula- tion. Supporters of this practice maintained that it was ethi- cal to perform HIV tests without patient consent because the samples did not carry any identifying information, and the results of the tests could provide important informa- tion about the prevalence of HIV in the community. Critics expressed concerns about the fact that patients who tested positive for HIV would not be informed of the results of their tests.7 In the early years of the HIV pandemic, when no treatment was available, there was a consensus that, given the population-level benefit of gathering accurate data on the prevalence of HIV infection, this mode of surveillance was ethical and, in fact, might be obligatory for states con- fronting the emerging epidemic. Over the past decade,Source: WHO.however, as prospects of treating HIV have improved, the argument has shifted. Today, anonymous testing of blood samples for HIV would probably not be approved by an eth- ics committee, as it would be considered ethically inappro- priate to identify individuals as HIV-positive without being able to follow up with treatment. This example shows how ethical policy-making is a dynamic process that must be adapted to the evolving situation.6. What are key ethical issues in health research?The goal of biomedical research is the creation of knowl- edge to improve the health of populations. Ethical ques- tions in research include:¢ Does the research have social value for the communi- ties that take part or from which the participants are drawn?¢ Who benefits from the research?
B. Health ethics in practice : key issues and challenges15
- ¢ Are subgroups of the population treated fairly?
- ¢ Are the rights and well-being of individual research par-ticipants protected?These issues are explored in detail in international ethical guidelines on research, including the World Medical Asso- ciation’s Declaration of Helsinki,8 the Council on Interna- tional Organizations of Medical Sciences’ International ethical guidelines on biomedical research involving human subjects,9 and various research ethics guidelines issued by WHO.10 The discussion below highlights some of the major points covered in these guidelines; readers are encouraged to consult the guidelines themselves for additional detail.Research aims to improve all of our lives by testing exist- ing and new treatments, preventive measures, and systems and procedures. Health care research has undoubtedly pro- duced great public health benefits. However, research also brings to the fore several ethical concerns for the groups and individuals that contribute to or take part in research, as described below.Ethical issues regarding groups¢ Social and economic disparities at national, regional and global levels magnify concerns that efforts to improve the health of some populations might have the unintentional consequence of making things worse for others. When studies are carried out in disadvantaged societies, the members of those societies who take part are being put at risk, while – because of their economic or social disadvantages – they may not be able to ben- efit from the knowledge gained by the study. Unfair- ness can be reduced or eliminated by ensuring that study populations enjoy the benefits of the research. At the same time, great caution is required when the only chance for medical care is linked to participation in biomedical research studies. This is a problem in resource-poor countries, as well as for people of low socioeconomic status in wealthy nations.¢ Ethical questions also emerge in the selection of topics for research. The health concerns of affluent popula- tions often drive the research agenda, leading to the development of new drugs and devices for which there is a large (and profitable) market. The health problems of resource-poor populations offer fewer opportunities for commercial success and therefore tend to receive less attention from investigators, exacerbating dispari- ties between rich and poor.
A fragment of the Hippocratic Oath on papyrus (verso showing oath), circa 3rd century
Source: Wellcome Library, London.¢Another ethical challenge arises when businesses or individuals patent new drugs or devices to help ensure that product sales recoup investments and generate profits. While laws that protect intellectual property can provide valuable incentives for research and devel- opment, they also increase the price of new drugs and devices, and can thereby severely restrict or pre- vent access to life-saving therapies for resource-limited populations. This issue has generated intense debate within the HIV/AIDS community, and in some cases has led to the development of proposals for or implemen- tation of alternative financing mechanisms designed to reduce economic barriers to essential treatments. (See also question 9.)Research in public health and epidemiology presents a number of distinctive challenges, including: the ques- tion of whether it is always necessary to obtain individ-¢
16B. Health ethics in practice : key issues and challenges
ual informed consent from participants in large observa- tional studies; issues of privacy and confidentiality in the collection and storage of personal health information; and how best to communicate study results to partici- pants and the public. Public health workers and epide- miologists continue to debate the differences between research and disease surveillance, and the question of whether or not they have – or should have – different ethical requirements.Ethical issues regarding individualsInternational standards tend to focus on the rights of indi- viduals who may participate in research, and prescribe procedures meant to ensure that potential research sub- jects have the freedom to choose to participate or not. In order to do this, prospective participants must be able to understand and appreciate the information they are given, the information about risks, potential benefits, and alter- natives must be clear and comprehensive, and individuals must understand that they are free to decline to participate or to withdraw from the study at any time.Managing ethical dilemmasThe human research enterprise will always be subject to an array of influences generated by investigators’ interests, sponsors’ requirements, subjects’ motivations (altruism, hope, desperation) and the prevailing social conditions. These influences create the potential for systemic prob- lems that cannot be solved solely by following guidelines, but require ethical integrity on the part of researchers and research organizations if they are to proceed with fairness and prudence. However, the history of research has dem- onstrated that this is not enough. Researchers and research organizations are often too involved in the research to remain disinterested in the outcome, and are often unable to view the research project dispassionately. Therefore, several mechanisms have been established to ensure that research projects are designed and conducted in an ethical manner.
- ¢ Research ethics committees perform the important role of assessing the potential risks and benefits involved in research. In some cases, such committees may decide that the risks of the study are not justified by the poten- tial benefits and decide not to allow the research to go ahead.
- ¢ In the case of clinical trials and other large commu- nity-based trials, data safety monitoring boards (DSMBs)
or their equivalent are established to ensure, among other things, that the safety concerns – as they arise in research – are addressed promptly and adequately.¢ In many clinical trials, clinical monitors are appointed to independently monitor the conduct of the research, including whether it is conducted as approved by the ethics committee.7. What are key ethical issues in clinical care?Most health practitioners want to do what is best for their patients. Non-maleficence (“first do no harm”), benefi- cence (doing good) and trust are fundamental ethical prin- ciples at the heart of clinical care. Health practitioners also seek to ensure that patients are given adequate informa- tion, are consenting to treatments and procedures volun- tarily, and have the capacity to understand and appreciate the potential benefits and risks of the care they receive. Health practitioners seeking to provide the best possible care to their patients in the most ethical manner may find it difficult to balance the right to information with the need to avoid information overload. Some common challenges in clinical ethics are outlined below.¢¢¢How much information is adequate? How should com- plex medical information be communicated to patients who may be frightened or feeling ill, and may have trouble assessing risks, benefits and alternatives? Do all patients even want a great deal of information? Some may prefer to trust their health provider to do what is best for them. When, if ever, is it permissible for a pro- vider to withhold information from a patient because the patient does not appear to want it?When, if ever, should a clinician’s professional opinion or treatment recommendation take precedence over a patient’s right to make a voluntary and free decision to accept or reject treatment? Is paternalism (i.e. acting to bring about something for another individual’s own good) ever permissible?What criteria should be used to assess whether a patient has the capacity to make his or her own decisions about treatment? How much preparation and information should a surrogate or proxy have before making a health decision for someone else?Other important ethical issues in clinical care relate to pri- vacy and confidentiality. These are longstanding values in
B. Health ethics in practice : key issues and challenges17
Guatemalan children living in refugee camps in the State of Campeche wait to get their food ration.
Source:UN Photo/Pat Goudvis.many cultures. Privacy and confidentiality should be pro- tected, first because there is wide agreement that people have the right to control who has access to their person or to information about them. Secondly, the ability to provide high quality medical care depends on patients feeling free to communicate fully and truthfully with their caregivers. Fur- thermore, individuals could face stigmatization and discrimi- nation if certain medical information, such as about sexually transmitted diseases or mental illness, is not carefully pro- tected. Respecting privacy and confidentiality carries special importance in an era of electronic medical records.However, not every issue in clinical ethics is about individu- als. For example, the way that people access health care, what services are provided, how they are funded, and how much patients have to pay at the point of delivery, all raise important ethical questions about how health care systems are set up. In this way, ethical issues in clinical care are often linked to larger ethical questions related to health care organizations and systems.8. What are key ethical issues of health organizations and systems?Ethical issues arise in the governance and management of health institutions and systems, particularly where there are competing stakeholder needs and values. Some exam- ples are given below.¢Resource allocation across health services and programmes. How should priorities be set to ensure that resources are allocated fairly and appropriately to meet the community’s health needs? How much prior- ity should be given to disease prevention as opposed to treatment? In a public health crisis, such as an influenza pandemic, who should have priority access to vaccines, drugs, and hospital services? Because normal health care systems may cease to function during a severe public health crisis, efforts should be made to achieve consensus on these questions in advance.¢Corporate partnerships and philanthropic fun- draising. In the face of scarce resources, are there restrictions on the kinds of funding sources from which a health institution may accept support? What if there is a conflict of interest between the values of the poten- tial funder and the health institution?¢ Workplace ethics. What obligations do health institu- tions have to their staff to ensure that the workplace is safe, respectful, and just? What supports ought to be in place to assist staff at all levels in dealing with ethical issues in their daily practice?¢ Equitable access. What obligations do health institu- tions or systems have to care for the uninsured, patients beyond their catchment area or jurisdictional borders, or future patients?¢ Individual versus population health. How much priority ought to be given to population health needs versus individual patient needs, if not all needs can be met? This question overlaps with the issues discussed above regarding the appropriate allocation of resources between prevention and treatment.¢ Public accountability. What obligations do health institutions and systems have to the communities they serve to be transparent about how health resources are used and to reflect community values in their decisions?In some cases, these issues may highlight the challenge of resolving tensions between different ethical values, such as efficiency, equity and choice. The decisions made may have significant implications for patients, families, clinicians, and other key stakeholders.Organizational and health system ethics are also con- cerned with the institutional environment within which decisions are made and the conditions that contribute to the development of a culture that supports and reinforces ethical decision-making. Experience shows that the insti-
18B. Health ethics in practice : key issues and challenges
Local health staff work with experts from Médecins Sans Frontières to disinfect the house of a patient who died of Ebola. Democratic Republic of the Congo, 2007.
Source: WHOtutional decision-making culture and context are often shaped by the behaviour of local leaders. Accreditation bodies are increasingly emphasizing the importance of eth- ical accountability at the highest level of health organiza- tions, are giving increasing attention to defining the moral attributes and competencies of ethical leadership, and are developing standards to monitor and evaluate ethical per- formance of health organizations.9. What are key ethical issues in global health?Considerations of justice are central to global health. While access to good health may be thought to be a vitally impor- tant ethical principle, it remains unavailable to most peo- ple. Health in low-resource countries is often compromised by social determinants, such as poverty, malnutrition, poor education, unhealthy living conditions, and lack of accessto health care, as well as by corruption in the public and private sectors. The global health care status quo reflects a collective failure of the international community to meet the most basic needs of most of the world’s population. An urgent challenge in global health ethics is to specify the actions that wealthier countries should take, as a matter of global justice and solidarity, to promote global health equity.The problem of limited access to health care in resource-poor countries has been exacerbated by a “brain drain”.11 Health professionals trained in resource-poor countries are com- monly recruited to work in wealthier countries, resulting in a severe shortage of health care workers in the former. This raises questions about the ethical acceptability of such recruitment and the incentives that might be used to dis- courage emigration. This is another case of a moral con- flict – between the freedom to relocate and associate freely and the need to improve the health of some of the most vulnerable people.
B. Health ethics in practice : key issues and challenges19
Another set of ethical issues in global health is related to cultural relativity. It is sometimes asked whether ethical standards are universal, given that different people in dif- ferent countries may hold different values or place different weights on common values. For example, some practices that are widely condemned by the international commu- nity, such as female genital mutilation, may still be carried out by certain social groups in accordance with specific religious or cultural beliefs. While some people may argue that condemning such practices as human rights violations constitutes a form of ethical imperialism, others strongly argue that we must stand up for the women and children who are at risk of being harmed.A third challenge in global health ethics concerns interna- tional research, especially where investigators from wealthy countries conduct research in impoverished settings where participants are especially vulnerable or where language and cultural barriers make informed consent difficult. One of the most hotly debated issues regarding international research ethics during the past two decades has been about standards of care: what level of care should be pro- vided to participants in the control arm of a clinical trial in settings where the usual standard of care is especially low? And what level of care or other benefits should be pro- vided to participants or participating communities at the conclusion of a trial?
20B. Health ethics in practice : key issues and challenges 
C. Health ethics in practice: key strategies
C. Health ethics in practice: key strategies21
10. What role can ethical theories and principles play in addressing ethical issues?Ethical theories and principles are helpful in addressing eth- ical issues in two key ways: (1) they explain why the issue at hand is an ethical issue, and (2) they justify why one course of action ought to be preferred over another. Ethical theo- ries provide a coherent system of thought about what con- stitutes ethical action and tend to be abstract; ethical prin- ciples are more narrowly focused and provide the basis for specific rules or norms that can be more readily applied in practice. Some ethical theories focus on the consequences of decisions to determine what the right course of action should be. For example, utilitarianism is a consequentialist theory, which holds that resources should be allocated to achieve the best overall outcomes, e.g. improved popula- tion health. Other ethical theories hold that certain types of action are categorically wrong, regardless of their con- sequences. For example, some people maintain that it is inherently unethical for physicians to actively hasten a patient’s death, regardless of the patient’s wishes or how much the patient may be suffering. Some theories are pri- marily concerned with how decisions are made (are deci- sions made rightly?), rather than what decisions are made (what is the right decision?). Some ethical theories aim to achieve greater social justice by considering the social and institutional conditions that shape the health of individuals and populations.In practice, different theories may overlap regarding judge- ments about what to do within health ethics. For example, both utilitarian and egalitarian approaches to ethics may suggest a redistribution of health resources in response to socioeconomic constraints on health. Moreover, how dif- ferent ethical principles are applied will necessarily depend on the specific context. For example, while respect for indi- vidual autonomy can be seen as operative in the empha- sis on informed consent for both treatment and research, in a public health context, autonomy may be constrained when doing so is the only means of protecting the public good. In health policy more generally, respect for auton- omy may be expressed in efforts to engage affected stake- holders in shaping the policies that will affect their lives.11. What is the role of ethical decision‐making frameworks?Ethical decision-making frameworks provide systematic and practical approaches to the analysis of ethical issuesand questions. They aid decision-making by framing the ethical issue at hand (what type of ethical issue is this?), making relevant values and ethical principles explicit (what is at stake, and for whom?), providing a structure for deter- mining how to address or resolve the ethical issue (what actions ought to be taken?), and ensuring consistency in similar situations and across decision-makers. Ethical frameworks may consist of a set of procedures to be fol- lowed in addressing an ethical issue or a set of criteria to be factored into a decision, or both.A procedural ethical framework provides guidance on how decisions ought to be made and by whom. For example, when faced with a complex ethical challenge involving mul- tiple stakeholder interests, values, and needs – e.g. how to prioritize access to antiretroviral drugs – a procedural justice framework emphasizing principles of transparency, inclusiveness, and revisability may be necessary to establish the ethical legitimacy of the policy. A substantive ethical framework specifies what decisions ought to be made with reference to pre-agreed criteria. For example, in deciding where to invest resources in primary care services, the prin- ciple of equity – in terms of reducing preventable health inequalities or addressing socioeconomic factors influenc- ing health – may be an overarching ethical consideration.Ethical frameworks must generally be tailored to the ethical issues and challenges at hand. Hence, although they may appeal to similar ethical principles, there are likely to be different ethical frameworks for questions related to public health surveillance and for individual treatment decisions.12. What are the roles of ethics committees in addressing ethical issues in health?Ethics committees are institutional structures that provide a deliberative forum in which ethical issues can be anal- ysed and addressed. They are generally comprised of mul- tiple stakeholders and relevant content experts, to ensure a robust assessment of the ethical issues and an ethically justified and empirically informed identification of solu- tions. There are three common types of ethics committee: national ethics committees, research ethics committees, and clinical ethics committees.¢National ethics committees (NECs). A number of countries have created official bodies to advise their executive and legislative branches, and often the gen- eral public, about ethics of health and health care. They may be appointed by the chief executive, min-
22C. Health ethics in practice: key strategies
Source: WHO/Christopher Black.ister of health or legislature to analyse ethical issues and offer conclusions and policy recommendations. In some countries, the bodies that serve this function are appointed outside formal governmental structures, and may comprise several advisory groups. Since 1996, NECs have met every two years at the Global Summit of National Bioethics Advisory Bodies, the purpose of which is to facilitate international dialogue and to fos- ter consensus on ethical issues of global concern. WHO serves as the Secretariat of these Global Summits.¢ Research ethics committees (RECs). RECs review proposed human research studies to ensure that they conform to internationally and locally accepted ethical standards. The main responsibility of RECs is to evaluate research protocols with the aim of safeguarding par- ticipants’ rights and well-being, by ensuring that the risks of the research are minimized, that they are rea- sonable in relation to anticipated benefits, and that the researchers have made adequate plans for obtaining participants’ informed consent. Other responsibilities of RECs include: assessing the recruitment process and any incentives that will be given to participants; evaluating risks to participants’ confidentiality (and the related risk of potential discrimination) and the adequacy of mea- sures to protect it; and ensuring that the participants and their communities are not exploited. Some RECs operate within research institutions, where they may be referred to as institutional review boards, while others operate at the regional or national level. The advan-tages of an institutional committee are that it is familiar with the local context and can closely monitor ongoing studies. On the other hand, an external committee may provide greater consistency and carry greater legitimacy in the eyes of the research community and the broader public.¢ Clinical ethics committees. Clinical ethics committees are an important instrument of clinical decision-mak- ing on ethical issues arising from the provision of care in health care institutions. Clinical ethics committees are usually multidisciplinary and may include ethicists, health care professionals, patient advocates, and reli- gious representatives. They provide guidance to clini- cians, patients, and families in clinical dilemmas and may also contribute to the development of institutional policies and procedures.13. What role should citizens, community members, and other stakeholders play in addressing ethical issues?Health policy decisions can be ethically challenging as a result of multiple health system or institutional goals (e.g. health promotion vs health care), competing stake- holder interests (e.g. funder vs health provider), conflicting values (e.g. equity vs utility), or incomplete information, for which there is no obvious or “rationally” correct policy
C. Health ethics in practice: key strategies23
answer. Although ethical theories and principles provide insight into the nature of the ethical issues, they cannot in themselves address the empirical and ethical uncertainty in policy decisions that have wide-reaching implications for patient groups, communities, and populations. Expert opinion is often a valuable resource to inform such deci- sions; however, many ethicists believe that the ethical legit- imacy of health policies also depends on the appropriate engagement of affected stakeholders, including citizens, patient populations, communities and nongovernmental organizations (NGOs). For example, the “accountability for reasonableness” framework (see glossary of terms) requires that rationales for decision-making be publicly available. Stakeholder engagement is especially important in pluralistic societies, where different people may have dif- ferent ideas about how much weight should be placed on various values or how a balance should be struck between competing values in cases of conflict. There are three com- mon reasons for engaging affected stakeholders: (1) toimprove the quality of decisions by examining ethical issues from diverse perspectives and bringing relevant experience and expertise, both lay and professional, to the table; (2) to provide input on values, to inform policy decisions and guide the application of available evidence; and (3) to pro- vide a mechanism for improving public accountability for these decisions. Stakeholders can be engaged in a num- ber of ways, including through surveys, interviews, and focus groups to elicit relevant stakeholder values, public meetings to discuss policy issues, citizens’ councils or com- munity advisory panels to provide direct input into policy deliberations, referenda and other shared decision-making processes. Civic deliberation and public participation in the policy process require that those involved understand the facts, the areas of uncertainty and risk, the reasons used to justify public health interventions, the goals of such interventions, and the steps that will be taken to safeguard individual rights.
24C. Health ethics in practice: key strategies 
D. Health ethics and the World Health Organization
D. Health ethics and the World Health Organization 25
14. Why is health ethics important for the work of WHO?One of WHO’s six core functions is to develop “ethical and evidence-based policy options.”12 This requires a clear understanding of the nature of ethical analysis in health care decision-making. WHO, as a member of the United Nations family, is bound by internationally accepted prin- ciples of human rights, which provide an important — and non-negotiable — ethical framework for work and research in health and health care. However, the existence of an overall ethical framework for decision-making in health does not eliminate the need for ongoing ethical analysis. In many situations in public health policy, multiple ethical considerations will be relevant. While principles of human rights must guide the analysis of these issues, those prin- ciples often do not point to a single, objectively correct answer. Rather, an ethically acceptable decision can only be reached by articulating the full range of relevant norma- tive considerations, ensuring that multiple perspectives are factored into the analysis, and creating a decision-making process that is considered fair and legitimate by the relevant stakeholders. At the same time, it is essential to remem- ber that ethical decision-making is not simply a matter of determining the majority’s point of view. Ultimately, any decision that is reached must be consistent with funda- mental human rights norms.In 2002, WHO established a dedicated ethics team, which is now called the Global Health Ethics Unit. Through thisThe 60th World Health Assembly opens in Geneva, Switzerland on Monday, 14 May 2007.
Source: WHOteam, WHO works in close collaboration with other inter- national organizations and NGOs, and the UN Interagency Committee for Bioethics. The mandate of the Unit is to provide a focal point for the examination of ethical issues raised by activities throughout the Organization, including the regional and country offices, and to foster discussion and debate on a wide range of topics in global health ethics.15. How does WHO support health ethics capacity‐building in Member States?One of the most important objectives of the Global Health Ethics Unit is to build and strengthen capacity in WHO Member States in relation to a wide range of global health ethics topics.13 This is done initially through the elaboration of guidance at global level. The publication of WHO guid- ance documents is usually followed by implementation activities at regional and country levels, aimed at ensuring that the guidance is used and adapted to the local set- ting. Workshops and training with key stakeholders, such as Ministry of Health officials, public health experts, and patient groups, are organized. For example, the Global Health Ethics Unit led the process of developing guidance for Member States regarding the fair distribution of antiret- roviral treatment in response to the HIV epidemic.14 With regard to preparedness and response to pandemic influ- enza, the Unit developed advice for planners on how to confront ethical issues of isolation and quarantine, and fair access to services during pandemics.15 It also collaborated with WHO’s Stop TB Programme in developing guidance on ethical issues related to tuberculosis care and control.16 In 2010, the World Health Assembly adopted guiding principles on organ and tissue transplantation to support Member States in developing an ethical framework for transplantation.17WHO has
