WHO Research Paper

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One of WHO’s core functions is to articulate “ethical and evidence-based policy options” for its Member States, placing ethics at the core of WHO’s work. Since its establishment in 1948, various programs of WHO have addressed ethical issues that arise in a broad range of health topics. The Global Health Ethics Unit, WHO’s focal point for ethics, provides WHO’s Member States and their public health programs with guidance on ethical issues that arise in their policies. The Unit develops global guidelines on ethics and collaborates with Member States in capacity-building activities. This entry first describes the mission and functions of Global Health Ethics and the history of health ethics at WHO, then discusses the main areas of work, such as public health ethics, pandemic response, and research ethics, and finally informs about the main partnerships.


WHO’s central role in promoting public health in its Member States, and its core function to articulate ethical and evidence-based policy options, places ethics at the heart of WHO’s work. There is an expectation that the Organization ensures that all public health policies, programs, and activities are founded upon a robust ethical framework. The Global Health Ethics Unit (GHE) provides a focal point for the examination of ethical issues raised by activities throughout the Organization and supports WHO’s Member States in addressing ethical issues that arise in their health programs. This includes a range of global bioethics topics, from public health surveillance to developments in genomics and from research with human beings to fair access to health services. This Unit’s work is particularly important in the context of contemporary health challenges and raises and addresses difficult questions in areas such as resource allocation, new technologies, decision-making in clinical care, and public health.

One key function of GHE is to provide WHO’s Member States and their public health programs with guidance on ethical issues that arise in their policies. In developing ethics guidelines, a characteristic of WHO’s work is the close collaboration with technical units and end-users in countries, a process which often results in documents that are quite applied, in contrast to merely stating high-level principles.

Another important function of the Global Health Ethics Unit is to build and strengthen capacity in WHO Member States to develop mechanisms that enable a reflection on and incorporation of ethics in relation to a wide range of public health programs and policies, and to provide tools that support this reflection (WHO 2015). The Unit also supports Member States in establishing ethical standards for conduct of health research, and in specific research areas, and provides tools that can support their implementation. This is done initially through the elaboration of guidance at global level. The publication of WHO guidance 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 setting. Workshops and trainings with key stakeholders, such as Ministry of Health officials, public health experts, and patient groups, are organized, often together with WHO’s Regional and Country Offices.

WHO has an ethics focal point in each of its six Regional Offices; they are responsible for building ethics capacity and addressing issues at regional level in coordination with WHO’s country offices. For example, the Regional Program on Bioethics of the Pan-American Health Organization/WHO Regional Office for the Americas was already established in 1994. Based on a resolution by the Pan-American Sanitary Conference, this Program has a specific mandate to work on research ethics and bioethics in the Americas (Pan American Health Organization 2012). Their proximity to the countries helps them to tailor the global guidance to the local context and to ensure that questions with local relevance for Member States are addressed at the global level. Support for ethics capacity building among WHO Member States is further strengthened through collaboration with ethics experts affiliated with the WHO Collaborating Centres for Bioethics.

Besides an external role in advising its Member States, WHO’s activities on ethics also serve important internal purposes. In order to ensure that WHO’s own projects and activities adhere to the highest ethical standards, the Organization has established two internal oversight mechanisms at Headquarters, and the Unit serves as the technical support secretariat for both of these.

The Research Ethics Review Committee (ERC) is a 27-member independent and autonomous committee established and appointed by the Director-General. Its mandate is to ensure that all of research supported by WHO adheres to the highest ethical standards. The ERC reviews all research projects that involve human participants and are supported either financially or technically by WHO. While the majority of the committee consists of WHO staff, to ensure transparency and accountability, the Committee also includes international external individuals as members, who have the same rights and responsibilities as the WHO staff members. Members bring with them valuable and extensive experience and knowledge in research in different fields and receive appropriate training in research ethics before commencing their role within the ERC. The broad range of research expertise of Committee members, together with the ethics training, ensures that all proposals are thoroughly and fairly reviewed for ethical research conduct.

The ERC is guided in its work by the World Medical Association’s Declaration of Helsinki (1964) last updated in 2013, as well as the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS 2002) and functions according to prior established Rules of Procedure. The ERC is supported by a small secretariat, which is usually under a research department for administrative purposes; its support to the ERC and the functioning of the Committee is independent of administrative oversight; to uphold its independence, the ERC reports only to the Director-General and only through the elaboration of an annual report. The ERC reviews an average of 110 new protocols per year and provides oversight, on an annual basis, to an average of 50 ongoing protocols. The Committee fulfills its oversight role, through the review of Data Safety Monitoring Board (DSMB) reports, requested amendments, and reports of protocol deviations.

When research involves human beings – as health-related research often needs to – it invariably involves risks to research participants and communities and raises issues that impact on and have relevance for autonomy, justice, fairness, and beneficence (or lack of it). These are compounded when the research is of a global dimension and involves more than one country, or when it is carried out on poor, vulnerable populations that are already stigmatized for various reasons. The function of the ERC is to ensure that all of research supported by WHO maximizes the benefit risk ratio, protects the interests of the research participants, especially those who are vulnerable, and is carried out in accordance with the fundamental ethical principles of respect, beneficence, and justice as laid out in internationally accepted norms of ethics.

Although public health activities raise similar ethical issues, within most organizations no formal mechanisms currently exist to provide advice to public health practitioners on how to identify and address ethical issues in their projects. In order to promote high ethical standards in public health projects, in 2015 WHO officially launched the Public Health Ethics Consultation Service, with corresponding terms of reference, rules of procedure, a review template, and other supporting materials for the work of the Public Health Ethics Consultative Group (PHECG), which provides the consultative services.

In addition to these two mechanisms, WHO at Headquarters also created a Department of Compliance, Risk Management and Ethics (CRE), to ensure that its staff members also adhere to the highest ethical standards in their professional work. Its objective is to pursue excellence at all levels of WHO in an effective, efficient, transparent, and accountable way. Operational since January 2014, CRE’s work is geared toward improving transparency and accountability through enhanced compliance, the development and management of a corporate risk framework, and improved focus and emphasis on ethical values.

History Of Health Ethics At WHO

One of WHO’s six core functions is to develop “ethical and evidence-based policy options.” Indeed, since the establishment of WHO in 1948, ethical issues have been at the core of its mandate and discussion of its governing bodies has included debates about ethics. WHO’s Constitution of 1948 states that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition” (WHO 1948), which is in itself a strong ethical claim. Conduct of health research to the highest standards is also enshrined in the constitution of the Organization, and in order to operationalize this mandate, the Organization established an ethics review committee which has been functional since 1978. Originally named the Secretariat Committee for Research Involving Human Subjects (SCRIHS), it was strengthened in 2002 in response to the increasing globalization of health research and was renamed the Research Ethics Review Committee in 2004. In 1982, the UN General Assembly in a resolution invited “all relevant intergovernmental organizations, in particular the World Health Organization, and non-governmental organizations concerned to bring the Principles of Medical Ethics to the attention of the widest possible group of individuals, especially those active in the medical and paramedical field” (United Nations General Assembly 1982). Early WHO publications and resolutions on ethics include the “WHO ethical criteria for medicinal drug promotion” (1992), “Guidelines on ethical issues in medical genetics and the provision of genetics services” (1995), and “The teaching of medical ethics” (1995).

In 1994, the Pan-American Health Organization/WHO Regional Office for the Americas already established a Regional Program on Bioethics. Although ethical issues had been dealt with in different WHO departments and programs for decades, it was not until 2002 that WHO established a dedicated ethics team, which is now called the Global Health Ethics Unit.

As discussed in the “Introduction” section, this Unit is the focal point of WHO Headquarters for addressing ethical issues, but continues to have focal points in other technical departments, and Regional and Country Offices.

Main Areas Of Work

WHO’s work on Ethics reflects the organization’s broad mandate for health, as the “directing and coordinating authority on international health work” (WHO 1948). It thus encompasses the full range of ethical issues arising in health care and health policies. In the following section, a few highlights will be discussed. Roughly speaking, the work can be divided into two major areas, although this separation has over the years become increasingly artificial:

Public Health Ethics

Ethical issues that arise in public health programs are at the core of WHO’s work on ethics. Over the years, a particular focus has developed in the area of infectious diseases.

Since the 1990s, WHO has been dealing with ethical and human rights issues raised by the HIV epidemic. From the beginning, stigma and discrimination of people living with HIV has been a major challenge. Jonathan Mann, the first director of the WHO AIDS program, was at the forefront of the early days of this struggle. Of great importance has been the drive toward universal access to treatment and prevention for all, in particular for the most-atrisk populations. In 2004, WHO jointly with UNAIDS published an important document, entitled: “Guidance on ethics and equitable access to HIV treatment and care” (WHO and UNAIDS 2004), which provided advice on the ethical issues that arise in the scale-up of ART and other HIV-related treatment and care programs. It aimed to support policy-makers concerned with planning and implementing these programs. Further, over the years, ethical modalities of HIV testing and counseling have been the focus of intense debates, as well as prevention methods, such as male circumcision, and HIV surveillance. More recently, the paradigm shift to “treatment as prevention,” as well as pre-exposure prophylaxis have sparked ethical controversy, which was addressed in a joint publication by UNAIDS and WHO.

Further, starting from 2005, ethical issues in the area of pandemic preparedness and response have received considerable international attention. WHO convened several international expert meetings on the subject, which resulted in a number of important publications. The guidance document on influenza (WHO 2007) received particular attention, as well as the WHO report on “Research in International Epidemic Response” (WHO 2009). Besides these international guidance documents, capacity building constituted an important element of the work, and more than 500 policy-makers and MoH officials were trained on ethical issues in pandemic preparedness and response. Since the early 2000s, WHO has also been working to address ethical questions that arise in tuberculosis prevention, treatment, and control. The collaboration with the national TB programs, as well as with the World Medical Association (regarding health care workers’ rights and duties), has been of special significance in this work. In 2010, the first international guidance document on “Ethics in TB prevention, care and control” (WHO 2010a) was published by WHO. As with pandemic influenza, raising awareness and training the national TB authorities has been a key part of WHO’s work in this area. The TB guidance document is currently undergoing a revision process (2015–2016).

In 2014, WHO launched a project to develop WHO Guidelines on Ethical Issues in Public Health Surveillance. Surveillance is one of the most fundamental activities of public health, involving different areas and practices such as noncommunicable disease registers, outbreak investigations, health systems research, and electronic means of data storage and transfer. Public health surveillance raises multiple ethical issues concerning, among others, the use/nonuse of informed consent or the provision/ nonprovision of standards of care. The guidelines are expected to be published in 2016.

Good Governance In Medicines

Good governance, stewardship, and structures that effectively ensure a certain level of accountability and transparency are prerequisites of any well-functioning health system. Unfortunately, in many countries, unethical behavior and corruption in the health care and pharmaceutical sector are widespread. The corruption found in the health system is often a reflection of more general problems of governance and accountability in the public sector. In 2004, WHO established the Good Governance for Medicines (GGM) initiative, in order to promote transparency and accountability in the pharmaceutical sector. The GGM “focuses on the fundamental need to have in place laws, regulations, policies, and procedures based on ethical principles to improve the management of pharmaceutical systems and create a corrupt-free environment to promote access to quality-assured medicines. Its primary emphasis is on prevention of corruption and on improving systems” (WHO 2014a). It is implemented in a three-step strategy to institutionalize good governance in the Ministries of Health. Since the very beginning of the GGM program in 2004, WHO’s Global Health Ethics Unit has been providing advice to the Department of Essential Medicines and Health Products and collaborating on the development of a conceptual framework and its implementation through tools. The GGM has so far been implemented in 36 countries.

Public Health Response To Emergencies And Disasters

While addressing ethical issues in provision of public health services remains one of the cornerstones of the work of the Unit, emergencies, disasters, and epidemic outbreak pose special challenges. The public health response must be mounted quickly, often with very limited resources, and in marginalized, poor, and vulnerable populations who are dealing not only with health challenges but also those related to food, security, and emotional and psychological pressures. In such circumstances, ethics can provide a framework and a rationale for decisions that need to be taken in less than ideal situations. The outcome of the ethical reflection can support the work of the public health professionals and their teams to better address the crises and provide more rational services. This was exemplified very clearly during the recent Ebola virus disease (EVD) outbreak, with an unprecedented geographical spread, a high mortality, and a complete lack of registered clinical interventions (both therapeutics and vaccinations). With near breakdown of the public health system in the affected countries, the repatriation of foreign workers to their home countries to obtain medical care brought to the fore the need to develop guidance on several areas of public health activities during an epidemic. An ethics panel and a working group that had a global representation were quickly established to provide advice to the Organization on various aspects of the epidemic (WHO 2014b).

Research Ethics

One of the primary ways by which the research enterprise ensures that health-related research and especially that which involves human beings is ethical is through the establishment of committees that review (and approve) these research projects from an ethical standpoint. Variously called ethics review committees, independent ethics committees, institutional review boards, etc., they are supposed to be independent committees that provide oversight to the research projects that are conducted by the entities that they are responsible for. The first such ethics committees were established around the early 1970s in the USA, in response to a recognition that ethical guidelines and declarations are not sufficient to ensure that research is conducted ethically. Subsequently most countries have established ethics committees but gaps invariably remain – both in developed and developing countries. For many years, WHO has been at the forefront of developing guidance and tools regarding ethical standards and procedures for research with human beings. More recently, “Standards and operational guidance for ethics review of health-related research with human participants” (WHO 2011a) was published to provide Member States with a tool to benchmark their activities in the area of research ethics. This document built upon the work of its forerunner and identifies 10 standards in six domains that include not only research ethics committees, but also the institutions that establish them, the researchers, the communities, and the national level leadership responsible for research. This document and its forerunner have made a significant impact on the way ethics of human subjects research is reviewed worldwide.

The Unit also works closely with other international organizations that develop research ethics guidance, such as the World Medical Association and the Council of International Organisation of Medical Sciences (CIOMS) and provides inputs to all international research ethics guidelines. Where guidance is lacking in specific areas, the Unit – following an exhaustive review of literature – develops guidance on that special area. Such gaps were identified in the area of patient safety research leading to the publication of the ethical guidance on patient safety research (WHO 2013) and in the area of health systems research leading to the initiation of the process to develop such guidance.

The normative work in this area is supplemented by capacity-building activities – through conduct of workshops for national or regional ethics committees and through development of tools for training. Most recently, WHO has been engaged in dealing with ethical issues which arise in Ebola virus disease (EVD). Since 2014, West-Africa has been ravaged by the worst outbreak of EVD ever witnessed. More than one year after its onset, the affected countries still continued to report many new cases. In this regard, the Global Health Ethics Unit has established an Ethics Working Group to develop ethical guidance for ethics committees, researchers, prospective participants in research trials, regulators, national authorities, and the wider public on different issues that have been raised in the context of the Ebola epidemic (WHO 2014c).

The Ethics Working Group has developed guidance on study designs for trials on therapeutics for Ebola virus disease, and the use of convalescent whole blood or plasma, and is developing guidance on the provision of care to children and their involvement in research, health workers obligations, and other relevant topics. The ERC had to review many research projects including several trials related to Ebola vaccines and therapeutics in which WHO was involved, in addition to its usual review. The rapid turn-around time for these projects of public health emergency increased the challenge, as for the national research ethics committees involved.

The “Casebook on ethical issues in international health research” (WHO 2010b), a compilation of case studies, has found a very widespread usage among research ethics committees and other stakeholders. Keeping with the times, the Unit has – in collaboration with the University of Oxford – developed an e-training course on research ethics, which is largely case study based and provides extensive links to ethics resources worldwide.

Dual-Use Research

Besides ethical issues in research with human subjects, WHO has also been addressing ethical quandaries raised by so-called dual-use research. The potential of research to be used for good, but also for malevolent purposes has been highlighted in the twentieth century by the development of chemical, atomic, and biological weapons. In the last decades, the focus has increasingly shifted to the dual use of life sciences research and its potential for bioterrorism. The most recent controversy involved the H5N1 virus – a strain more transmissible in mammals than those occurring naturally had been successfully created in 2011, reinforcing concerns about the risks and safety of such findings and the accidental or possible misuse of this knowledge.

Key ethical questions for consideration for decision-makers and health scientists are:

  • How to weigh the potential benefits of research against the risks for misuse? On which criteria should this assessment be based?
  • How to weigh the individual interests of researchers against the common good of public health? Who should make these decisions? How can tensions between individual researchers and institutions/society best be managed?
  • How to best manage the risks associated with research without hindering its beneficial application to public health?
  • What are the responsibilities of individual researchers and the scientific community as a whole to society? (WHO 2011b)

Global Partnerships

United Nations Inter-Agency Committee For Bioethics

In March 2003, led by UNESCO, representatives of a number of United Nations organizations and specialized agencies established the UN Inter-Agency Committee on Bioethics to promote coordination and cooperation among themselves and other regional and international intergovernmental groups that deal with the field of bioethics, including its human rights aspects and other related issues. WHO has been collaborating actively in this Committee since its establishment.

Global Summit of National Ethics Committees An increasing number of countries have created official bodies to provide advice to their executive and legislative branches, and often to the general public, about bioethics. Termed “National Commissions,” “Advisory Committees,” and the like, they are appointed by Chief Executives, Ministers of Health, and legislatures, to analyze and offer conclusions and recommendations about current issues in bioethics, and the ethics of health more generally, especially as such issues bear on potential needs to develop national policies and to adopt legislation.

In November 1996, the then-existing national bioethics commissions met at a 2-day “International Summit” in San Francisco, California, USA, at the invitation of the US “National Bioethics Advisory Commission” and the French “Comité Consultatif National d’Ethique pour les Sciences de la Vie et de la Santé.” Subsequent meetings of the Global Summit of National Bioethics Advisory Bodies, with ever-larger numbers of national committees and international organizations represented, were held in the following venues:

  • Mexico City, 22–24 June 2014.
  • Carthage: 26–28 September 2012.
  • Singapore: 26–27 July 2010.
  • Paris: 1–2 September 2008.
  • Beijing: 4–5 August 2006.
  • Canberra: 7–8 November 2004.
  • Brasilia: 3–4 November 2002.
  • London: 20–21 September 2000.
  • Tokyo: 3–4 November 1998.
  • San Francisco: November 1996.

Over the years, the Global Summit has become a biennial forum for national ethics committees to share information and experiences and formulates consensus on a wide range of prominent ethical topics. Past summits have formed the basis of international collaboration, agreement, and discussion on topical ethical issues affecting world public health. Since the year 2000, WHO has provided the Permanent Secretariat function for the Global Summit. In collaboration with UNESCO, WHO has also organized two Regional Summits of National Ethics Committees in the Eastern Mediterranean Region.

Global Network Of WHO Collaborating Centres For Bioethics

The Global Health Ethics Unit works together with the Global Network of WHO Collaborating Centres for Bioethics. WHO Collaborating Centres for Bioethics are academic centers specializing in health ethics, located in universities around the world. They represent an essential resource for WHO in implementing its ethics mandate. The scientific validity of WHO’s ethics work is enhanced by collaboration and dialogue with these academic centers. WHO also encourages connections and synergies between its collaborating centers to achieve better results, facilitate resource mobilization, and strengthen Member States’ capacity, in particular at the regional level. The University of Toronto Joint Centre for Bioethics, Canada, was designated as the first WHO Collaborating Centre for Bioethics in 2002. In the following years, several other centers were designated in the regions of the Americas, Europe, and the Western Pacific. In 2009, the Global Network of WHO Collaborating Centres for Bioethics was created, to advance WHO’s ethics mandate through enhanced collaboration and synergies across the collaborating centers. At present, the Network undertakes a wide variety of capacity-building, technical, and training activities in collaboration with WHO, on ethics issues related to, for example, public health surveillance, research ethics, pandemic preparedness and response, and tuberculosis. As of 2016, the Global Network of WHO Collaborating Centres for Bioethics consists of seven member institutions:

  • Centre for Human Bioethics, Monash University, Australia
  • Center for the History and Ethics of Public Health, Columbia University, New York
  • Joint Center for Bioethics, University of Toronto
  • National University of Singapore (NUS): Centre for Biomedical Ethics (CBmE)
  • University of Miami Ethics Programs
  • University of Zurich: Institute of Biomedical Ethics and History of Medicine
  • University of Stellenbosch, South Africa: Centre for Medical Ethics and Law

The Network has made essential contributions to several key WHO projects. For example, in the area of pandemic influenza preparedness, it played a key role in the development of a WHO guidance document and capacity building in Member States. In research ethics, numerous capacity-building activities and the identification of resources in dozens of countries have been supported. Regarding ethical aspects of Tuberculosis programs, the Network has made an important contribution to the development of the WHO guidance document and related training tool.

WHO is committed to the development of Collaborating Centres for Bioethics in low and middle-income countries and encourages active partnership between centers in high and low-resource settings. More collaborating centers are in the process of being identified.


WHO’s Global Health Ethics Unit has established a number of partnerships with key nongovernmental organizations in the field. For example, collaboration with the World Medical Association (WMA) included the revision of the Declaration of Helsinki and the development of guidance on ethics in pandemic influenza planning and ethics and tuberculosis. The Global Health Ethics Unit has also been intensively collaborating with the Council for International Organizations of Medical Sciences (CIOMS), in particular on the International Ethical Guidelines for Biomedical Research and the International Ethical Guidelines on Epidemiological Studies, as well as Médecins sans Frontières, the International Council of Nurses (ICN), and the International Committee of the Red Cross.


WHO develops guidelines on ethical issues arising in a wide variety of health topics and programs for its Member States. The Organization is also very active in capacity building, both in the area of research ethics and in ethical issues arising in health systems and public health programs, in particular in lowand middle-income countries.

New ethical challenges in health continue to arise, in particular in relation to epidemic outbreaks and pandemics, new medical technologies, and population aging. WHO will continue to provide advice and guidance to its Member States in these areas.


Andreas Reis and Abha Saxena are staff members of the World Health Organization (WHO). The authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions or policies of the WHO.

Bibliography :

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  17. UNAIDS and WHO. (2013). Guiding principles on ethical issues in HIV surveillance. UNAIDS/WHO Working Group on Global HIV/AIDS and STI Surveillance. Geneva
  18. WHO and UNAIDS. (2013). Ethics of PrEP and early initiation of art for prevention: How should countries reach a decision? Geneva

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