- Define health ethics and understand its role in public and global health research and practice.
- Review key ethical and human rights concerns as they relate to global health research and practice.
- Discuss pivotal case studies and histories related to human rights and health.
- Discuss some of the central treaties, conventions and guidelines related to ethical research and health as a human right
- Explore key ethical issues in Public and Global Health and the articulation of Health as a Human Right in practice.
- Health ethics
- Public Health Ethics
- Human rights
- Universal Declaration of Human Rights
- Nuremberg Trials
- Nuremberg Code
- Tuskegee Syphilis Study
- Declaration of Helsinki
- The Belmont Report
- Informed Consent
- Universal Health Coverage
- Watch this short video:
- Watch this short video: Ethics matters in health
- Listen to this short (4 minute 30 second) podcast: The U.S. government recruited Black men to watch them die
An African American male is tested and treated during the Tuskegee Study of Untreated Syphilis in the Negro Male. According to the Centers for Disease Control and Prevention, the study began in 1932 as U.S. Public Health Service medical personnel conducted these tests without the benefit of patients’ informed consent. (SOURCE: Courtesy photo from the Centers for Disease Control and Prevention/Released https://www.jble.af.mil/News/Features/Display/Article/260599/generational-trauma-former-chief-reflects-on-family-history-of-illness/)
NOTE: Most of the content of this section is adapted or directly quoted from existing sources. Readers should consider content in the paragraphs preceding in-text citations to be the work of the cited author, with some minor adaptations from Dr. Mari Dumbaugh. Paragraphs which are not cited and not part of a section marked as from another source are the original text of Dumbaugh et al (2021).
In this section we will explore where and how ethics and human rights intersect with Global Health. We will take a historical approach and explore key events in medical and Public and Global Health research and practice which led to global agreements on the rights of individuals. We will also understand how health ethics and the framing of health as a human right play out in practice. The Sustainable Development Goals are used to illustrate the many nuanced and gray areas in health ethics and health as a human right — as these concepts intersect with other rights like individual freedoms, bodily autonomy, authority, governance and the public good.
We hope you are ready for some critical thinking — let’s dive in!
What is Health Ethics?
Health ethics is the interdisciplinary field of study and practice that seeks specifically to understand the values underlying decisions and actions in health care, health research and health policy, and to provide guidance for action when these values conflict.WHO, 2015
Health ethics 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. Health 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 (WHO, 2015).
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 population risk, and logistic concerns about maintaining an effective and efficient delivery system (WHO, 2015).
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 ethics is increasingly on the curriculum in health professional and bioscience training, as well as programmes in health administration, health economics, public health, law, biotechnology (e.g. genomics) and environmental health. Though it is a comparatively young field, there is an extensive and growing international literature in the area, and many research efforts are devoted to understanding it. (WHO, 2015)
In the fields of Public and Global Health when we talk about ethics we are generally referring to the agreed upon frameworks through which we, as a collective group of Public and Global Health actors, make decisions.
These decisions might include topics and questions such as:
- How we prioritize health challenges.
- For example, is maternal mortality a more urgent Global Health challenge than, say, child diabetes or adolescent mental health?
- How we design interventions to address health challenges.
- Is a health intervention designed in a way that respects socio-cultural norms in a particular context — but also respects universal human rights?
- Does this intervention reach systematically marginalized populations who face the greatest challenges accessing health?
- Will this intervention actually hurt any populations, or create even greater health disparities?
- How we decide to distribute limited resources to different populations.
- If two communities have the same burden of disease but we only have the resources (financial or human) to address one community, how do we decide where to focus our resources?
- How do we ensure resource distribution facilitates health equity — offering the most assistance to those facing the most challenges in achieving optimal health?
- How we design and conduct research.
- Are research participants given all of the necessary information they need to make a fully informed decision about participating in our study?
- Do research participants face any risks by participating in our study? Do the potential risks to participants outweigh the potential benefits?
- Are participants empowered to refuse to participate or stop participating in a study and is our study free of coercion?
This does not mean, however, that all Public and Global Health actors will easily agree on how decisions are made.
For example, many policy makers believe that the cost effectiveness of interventions – the ‘amount’ of health that can be bought per dollar – should often dictate prioritization. However, others might say that adhering to cost-effectiveness as the major deciding factor in prioritizing health interventions will leave many people very ill with diseases which are curable — for example, if drugs for a certain disease exist but are very expensive, it would not be cost effective to pay for and give those drugs to individuals who are sick. In other words, we are essentially putting a price on human life, and only those who can afford to pay for health services have a full chance of achieving their full health potential.
What is Public Health Ethics?
Because public health actions are often undertaken by governments and are directed at the population level, the principles and values which guide public health can differ from those which guide actions in biology and clinical medicine (bioethics and medical ethics) which are more patient or individual-centered (CDC, 2017).
Public health ethics may be defined as the principles and values that help guide actions designed to promote health and prevent injury and disease in the population.Gostin, 2013
As a field of practice, public health ethics is the application of relevant principles and values to public health decision making. In applying an ethics framework, public health ethics inquiry carries out three core functions, namely:
1) identifying and clarifying the ethical dilemma posed,
2) analyzing it in terms of alternative courses of action and their consequences, and
3) resolving the dilemma by deciding which course of action best incorporates and balances the guiding principles and values.CDC, 2017
Public health policy, interventions and research are always the product of controversy, and often remain surrounded by controversy as they are implemented. Routinely in public health, scientific considerations blend with political and ethical conflicts, and questions of autonomy, individual rights, coercion, justice, community, the common good, the norms of research, and multi-cultural values are central (adapted from Jennings, 2003).
Ethical issues are rarely neat, tidy, or cut-and dried. The questions of genetics, international and community based research, the control of infectious disease, and others that have been selected for this program are particularly difficult. They pose ethical “dilemmas” rather than black and white moral questions. They involve quandaries about which well-informed persons of good will can reasonably disagree (Jennings, 2003).
Health ethics and public health ethics has arisen alongside bioethics and the two fields of applied ethics have many strong affinities and connections. Just as the perspective and focus of public health often differs from that of clinical medicine, however, so too are there important differences between bioethics and medical ethics, on the one hand, and health ethics and public health ethics on the other. In a nutshell, the difference can be characterized by the individualistic orientation of clinical medicine and the social or population based perspective of public health. Public health deals with patterns of disease, the social determinants of disease, and collective and institutional solutions to alleviate the risk or burden of disease in a population and to affect the distribution of health benefit and disease burden in a society, or globally (Jennings, 2003).
Nonetheless, public health should not overlook the rights, interests, and freedom of the individual. Whenever possible, public health goals should be reconciled with the promotion of human rights and the protection of civil liberties. If there is an inevitable clash between public health and civil liberties, then the situation must be open to public debate, the elements of the conflict should be made explicit, Introduction 3 and rigorous, critical reasoning should be brought to bear on the relative benefits and burdens of a particular policy or intervention (Jennings, 2003).
One of the best examples we can point to today is ethical dilemmas surrounding the COVID-19 pandemic. Ethical questions related to the pandemic and Public Health, which is by definition concerned with the health of the population, quickly intersected with questions about individual freedoms, bodily autonomy and health risks.
For example, you may have heard questions circulating in the news, by policy makers, health systems, health providers and private citizens such as:
- How much can governments restrict individual movement during lockdown orders?
- Can individuals be required to wear a mask? If they do not, and they are putting others’ health at risk against their will, should they face consequences?
- How do we weigh the benefits of policies such as lockdowns, quarantines and remote learning against the potential economic and mental health consequences for children and adults?
- Should individuals be required to be vaccinated to keep their job or attend school?
- If health care resources need to be rationed due to high demand, who should receive priority care and who should not?
- How should vaccinations be distributed globally? How much of an ethical obligation do high-income countries have to ensure low- and middle-income countries have access to vaccines?
The fields of Public and Global Health ethics touches on a range of issues and sub-fields of study. For example, the ethical issues relevant to preventing the spread of a global pandemic could be very different from the ethical issues relevant to responding to humanitarian crises which could be quite different from the ethical issues encountered when ensuring women have access to safe abortion services.
Read the box below to learn more about how the World Health Organization integrates ethics into their Global Health work. Note the diverse and broad range of ethics issues within the field of Global Health: from specific ethical considerations relating to vector borne diseases to ethical considerations of using digital technologies to universal health coverage. Visit the WHO’s website on developing guidance to address ethical challenges in global health to learn more.
WHO: Developing normative guidance to address ethical challenges in global health
Countries face a diverse range of bioethics issues. WHO supports policymakers and government by developing guidance using the best available expertise to meet the ethical challenges that arise in public health, clinical practice, health research and more.
Ethical considerations cut across all areas of health, and this is reflected in the wide range of health topics addressed by WHO’s ethics guidance. WHO has developed disease-specific guidance on ethical considerations relating to vector-borne diseases, Ebola, HIV, tuberculosis and COVID-19. Other priorities include the ethics of public health surveillance, human genome editing, digital technologies in health, ageing and universal health coverage. Ethical issues relating to research are an important focus, including implementation research, human challenge studies, research indicators, and research during outbreaks and emergencies. Furthermore, WHO’s Health Ethics & Governance unit provides feedback and ethics input into other WHO guidelines, training courses, manuals and policy briefs on topics such as epidemic and emergency response, research and clinical practice.
WHO Member States need ethical guidance that can be applied to a wide range of situations in very different demographical, cultural, socioeconomic and geographical contexts, and WHO is committed to making normative guidance which can be adapted to suit Member State needs. WHO is greatly assisted in this aim through the Health Ethics & Governance unit’s engagement activities.
The Health Ethics & Governance unit works together with the Global Network of WHO Collaborating Centres for Bioethics, which is a well-established network of institutions distributed throughout the world and with relevant expertise in this field. These institutions represent a valuable resource as an extended and integral arm of WHO’s capacity to implement its ethics mandate and ensure that its normative guidance is current, responsive, inclusive and of excellent quality.
WHO’s Health Ethics & Governance unit also provides the permanent secretariat for the Global Summit of National Bioethics Committees. By facilitating communication, collaboration and exchange between national ethics committees, WHO stays abreast of the current ethical concerns their countries have and responds to these needs.
Source: (WHO, 2021), https://www.who.int/activities/developing-normative-guidance-to-address-ethical-challenges-in-global-health
In this section of reading we will first explore some of the most historic and recognized frameworks used to guide ethics in medical, Public and Global Health and humanitarian research and actions and the events that led to their inception. We will then discuss the relationship between Health and Human Rights, beginning with a history of Human Rights. Finally, we will learn about some of the most pressing ethical issues facing the fields of Public and Global Health today.
Ethics & Medical, Public and Global Health Research
When we explore ethics from a research perspective, students should note that there are many other frameworks, agreements and documents which have also contributed to guiding ethical practices in these fields which we are not able to cover within the scope of this one section. In particular, there are many discussions about the ethics of doing research with systematically marginalized populations. This includes research by institutions, research groups and individuals from high-income countries with individuals from low- and middle-income countries. As you read through this section, think back to our discussions in previous sections about historical legacies and how unequal power dynamics between Public and Global Health actors and the populations they are ‘helping’ could affect the safety and rights of research subjects.
To learn more about different events which have changed the ways in which we practice clinical research click here.
The Nuremberg Trials & the Nuremberg Code (1947)
Ethical questions related to health, health care, and public health cover topics as diverse as moral issues around reproduction, state obligations in the provision of health care services, and appropriate measures to control infectious disease. Scholars and health care professionals have debated ethical questions related to health and health care since the earliest days of medicine. (WHO, 2021). Many of the frameworks and standards we use to make ethical decisions within medicine, Public and Global Health today were established in reaction to significant moments in history which signaled a need for defining, agreeing upon and formalizing ethical standards for health research and practice.
While many of the historic documents and agreements we will discuss in this section relate specifically to medical, Public and Global Health research, these frameworks are also applied to ethical considerations about Public and Global Health practice as well — including intervention development and implementation, cross-cultural collaboration and exploring questions of autonomy and power dynamics inherent in the fields of medicine, Public and Global Health and humanitarianism.
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 (WHO, 2021).
Between 1939 and 1945, at least seventy medical research projects involving cruel and often lethal experimentation on human subjects were conducted in Nazi concentration camps without the consent of the individuals. These projects were carried out by established institutions within the Third Reich (Nazi Germany) and fell into three areas: research aimed at improving the survival and rescue of German troops; testing of medical procedures and pharmaceuticals; and experiments that sought to confirm Nazi racial ideology. More than seven thousand victims of such medical experiments have been documented. Victims include Jews, Poles, Roma (Gypsies), political prisoners, Soviet prisoners of war, homosexuals, and Catholic priests (United States Holocaust Memorial Museum, n.d.). Children were also included in this research and experimentation.
The Nuremberg Trials were a series of legal proceedings tried by the American Nuremberg Military Tribunal. The first trial began on October 25, 1946. Twenty-three physicians, scientists, and other senior officials in the Nazi medical administration and the army were put on trial. Seven of the accused were sentenced to death and executed; nine were sentenced to long prison sentences; and seven were acquitted. Several major perpetrators were never tried for their crimes, among them Josef Mengele, doctor at Auschwitz-Birkenau, who escaped to South America; and Horst Schumann, who was judged physically unfit to stand trial in the 1960s.
The principles that emerged from the Nuremberg Trials of 1947, known as the Nuremberg Code, are broadly applicable to many types of health-related research involving human participants, including clinical trials (Schuster, 1997).
A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.NIH, 2017
The Nuremberg Code is the most important document in the history of the ethics of medical research. The Code was formulated in August 1947, in Nuremberg, Germany, by American judges sitting in judgment of Nazi doctors during the Nuremberg Trials (Shuster, 1997). Before the establishment of The Nuremberg Code, there was no established or agreed upon code of conduct for research with human subjects (McFann, n.d.).
The Nuremberg Code served as a blueprint for today’s principles that ensure the rights of subjects in medical research. While the Nuremberg Code is comprised of 10 principles related to ethical research, two of the most significant principles were a new, comprehensive, and absolute requirement of informed consent (principle 1), and a new right of the subject to withdraw from participation in an experiment (principle 9). Other principles included protecting research subjects to the greatest degree possible from physical or mental harm. (Shuster, 1997).
Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision whether to participate in the trial or not. After studying all aspects of the trial, the participant voluntarily confirms his or her willingness to participate in a particular clinical trial…The goal of the informed consent process is to provide sufficient information to a potential participant, in a language which is easily understood by him/her, so that he/she can make the voluntary decision regarding “to” or “not to” participate in the research study.Nijhawan et al., 2013
|The Nuremberg Code |
1. The voluntary consent of the human subject is absolutely essential.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill, and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
SOURCE: British Medical Journal. (1996). No 7070 Volume 313: Page 1448. https://media.tghn.org/medialibrary/2011/04/BMJ_No_7070_Volume_313_The_Nuremberg_Code.pdf
The Declaration of Helsinki (1964)
The British Medical Journal announced the emergence of the Declaration of Helsinki in its 18 July 1964 edition with the following words: ‘A draft code of ethics on human experimentation was published in the British Medical Journal of 27 October 1962. … A revised version was accepted as the final draft at the meeting of the World Medical Association in Helsinki in June 1964. … It is to be known as the Declaration of Helsinki’. Attached to this inconspicuous announcement was the just over 700 words of the text of the original Declaration of Helsinki. There seemed little indication at the time of how important this document would become in the context of research ethics (Carlson, Boyde and Webb, 2004).
The Declaration of Helsinki is a statement outlining the ethical principles for medical research involving human subjects that was initially adopted by the 18th Assembly of the World Medical Association in Helsinki, Finland in June 1964. The Declaration of Helsinki is a great example of how ethics in health care and research evolves: it has been subsequently amended by nine general assemblies of the association, at meetings extending from 1975 to 2013 (Peters, 2020).
Each subsequent update has clarified, expanded or contracted particular practices related to research and ethics with one version extending principles from researchers to physicians. The most recent revision of the Declaration states that research subjects should be compensated for any harm they may experience during the study and guaranteed access to the best treatments discovered during the study. It’s important to note the current updated version (2013) is the only official piece that replaced the other preceding versions. The old versions are not used or cited unless for historical purposes (Lehmann, 2021). Though addressed primarily to physicians, the Declaration’s principles provide an ethical foundation that is used by all involved in medical research involving human subjects (Peters, 2020).
One of the darkest episodes in the history of medical research – the horrific experiments carried out by doctors on concentration camp victims in Nazi Germany – was exposed at the Nuremberg trials of 1947. Emerging from the Nuremberg trials was a code of ethics setting out ‘standards to which physicians must conform when carrying out experiments on human subjects’. The original Declaration of Helsinki is seen as having its roots in the Nuremberg Code. Fluss (1999) identifies 12 markers of ethical research within the Nuremberg Code. He points out that, of these, 10 markers appear in the original DoH and two markers are abandoned.
The Nuremberg requirement that ‘The voluntary consent of the human subject is absolutely essential’ is changed and the DoH allowed consent to be given by the ‘legal guardian’ in cases of ‘legal incapacity’. The other abandoned ‘marker’ was the statement ‘During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible’. This somewhat confusing statement was eliminated in the original Declaration of Helsinki and appears to be covered most closely by the sentence: ‘The investigator or the investigating team should discontinue the research if in his or their judgement it may, if continued, be harmful to the individual’. This is, of course, in addition to the subject or subject’s legal guardian’s freedom to withdraw consent at any time.
The original DoH also states ‘In the field of clinical research a fundamental distinction must be recognized between clinical research in which the aim is essentially therapeutic for a patient, and clinical research the essential object of which is purely scientific and without therapeutic value to the person subjected to the research’. This led to the fundamental structure of the document. The paragraphs of the original and the first four revisions of the DoH are grouped under the headings:
- ‘Introductory statements’
- ‘I. Basic principles’
- ‘II. Clinical research combined with professional care’ and
- ‘III. Non-therapeutic clinical research’
(Carlson, Boyd and Webb, 2004).
|The Declaration of Helsinki |
Last revision in 2013
Currently, there are ten specific sections addressed within the Declaration of Helsinki. These areas guide physicians and other participants in medical research that involve human subjects.
Let’s look at these areas and how they influence best practices for clinical research today.
1. The risks and burdens vs. benefits
The Declaration of Helsinki states that medical research should only be conducted if its findings outweigh the subjects’ risks and burdens. The physician-scientists need to determine the impact that the research will have on participating persons and the potential benefits to them and other people affected by the disease. They must also monitor and mitigate any risks during clinical research. Should these risks outweigh the potential benefits, the researchers should immediately modify their techniques or stop the research altogether.
2. Protection of vulnerable groups and persons
Professionals undertaking research should ensure vulnerable groups and individuals receive special protection. Vulnerable groups and individuals are participating subjects who are more likely to be wronged or incur harm owing to their special status. Such groups and persons can include minor children, people with disabilities, the imprisoned, and racial or ethnic minorities.
3. The need for sound scientific inquiry
The principles of medical research must meet specific requirements and research protocols. Researchers should be well acquainted with all the knowledge of existing scientific literature and other crucial sources of information. They should also have a thorough knowledge of accepted techniques of experimentation. The study design should be explicitly described and justified in the research protocol.
Researchers are also required to provide critical information on:
–>Compensation for harm
–>Incentives for the subjects (ie payment or rewards for participating)
–>Potential conflicts of interest
4. Review of research protocols by research ethics committees
Before starting a study, researchers should submit their protocol for review by the Research Ethics Committee. The Research Ethics Committee is an assigned institutional review board made up of qualified experts. They provide objective comments, guidance, and the approval of research. Researchers need to seek the knowledge and approval of the committee before they amend the protocol. Once the study is finished, researchers are also expected to submit final reports that comprise their findings and conclusions to the committee.
5. Privacy and confidentiality
The Declaration of Helsinki also underscores the need for researchers to keep the personal information of the subjects confidential. The privacy and identity of the participating subjects should also be kept protected.
6. Obtaining informed consents
The Declaration of Helsinki states that medical research subjects should never be forced, bribed, or coerced to participate in clinical research. Their decision to participate should be purely voluntary. The researchers must obtain informed consent in writing from those willing to participate. When obtaining consent, the following information must be provided
–>Methods of study
–>The sources of funding
–>Conflicts of interest
A research subject also has a right to withdraw consent at any time during the study. Additionally, researchers must consider potential subjects incapable of giving informed consent due to their physical or mental incapacity. In these scenarios, researchers should obtain consent from a legally authorized representative, according to the Declaration of Helsinki.
7. Use of placebo
In general, researchers should test new interventions against existing accepted standards that relate to the best-proven interventions. In some cases, the new interventions can be compared to a placebo. This often happens where there is no proven intervention or when there is a need to assess the efficacy and safety of the intervention that is believed to present no additional risks to abstaining from treatment.
8. Post-trial provisions
Where intervention is deemed to be beneficial within a trial, researchers are required to offer a provision for post-trial access for all participating subjects.
9. Research registration and publication of results
The Declaration of Helsinki requires clinical researchers to register all studies involving human subjects in a publicly accessible database. Additionally, once the trial is complete, researchers have an ethical duty to disseminate the results. They are required to provide complete and accurate results. They should also disclose all the negative and inconclusive results alongside their positive findings
10. Use of the unproven intervention in clinical proactive
In the absence of a proven intervention, a physician-scientist can use an unproven intervention. However, this should only be done once appropriate consideration incorporating professional judgments, expert advice, and the committee’s oversight is done.
The Tuskegee Syphilis Experiment & The Belmont Report (1974)
Unfortunately, the ethical guidelines set forth in the Nuremberg Code and the Helsinki Declaration did not protect all individuals from harm, including in the relatively recent past in the United States (Moore, n.d.).
In 1932, poor, rural, black, male sharecroppers from Tuskegee, Alabama, were recruited to participate in an experiment conducted by the U.S. Public Health Service, with the aim of studying syphilis in black men. In exchange for free medical care, meals, and burial insurance, 600 men agreed to participate in the study. A little more than half of the men tested positive for syphilis, and they served as the experimental group (given that the researchers could not randomly assign participants to groups, this represents a quasi-experiment). The remaining syphilis-free individuals served as the control group. However, those individuals that tested positive for syphilis were never informed that they had the disease (Moore, n.d.).
While there was no treatment for syphilis when the study began, by 1947 penicillin was recognized as an effective treatment for the disease. Despite this, no penicillin was administered to the participants in this study, and the participants were not allowed to seek treatment at any other facilities if they continued in the study. Over the course of 40 years, many of the participants unknowingly spread syphilis to their wives (and subsequently their children born from their wives) and eventually died because they never received treatment for the disease. This study was discontinued in 1972 when the experiment was discovered by the national press. The resulting outrage over the experiment led directly to the National Research Act of 1974 and the strict ethical guidelines for research on humans described in this chapter. Why is this study unethical? How were the men who participated and their families harmed as a function of this research? (Moore, n.d.).
Listen to this 4 minute podcast to hear a narration of the Tuskegee Study, including the U.S. government’s apology more than 20 years after the study ended: The U.S. government recruited black men to watch them die
|To learn more about the Tuskegee Syphilis Experiment:|
‘You’ve got bad blood’: The horror of the Tuskegee syphilis experiment
The Appalling Tuskegee Syphilis Experiment
The U.S. Public Health Service Syphilis Study at Tuskegee (CDC resource)
Generational trauma: Former Chief reflects on family history of illness
The Belmont Report was written in response to the Tuskegee Syphilis Study and further enshrined the importance of informed consent and protection of systematically marginalized populations in research (Maddock 2019).
Following the Tuskegee study, Congress passed the National Research Act, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission met regularly for nearly four years, culminating in a four-day discussion at the Smithsonian Institution’s Belmont Conference Center in February 1976 (Maddock, 2019).
This video is a series of interviews with the professionals who worked together on The Belmont Report. High recommend watching this to understand the perspectives of those within the process:
The resulting Belmont Report summarized the three ethical principles the commission concluded should guide human research:
The Belmont Report: Three ethical principles should guide human research
Respect for persons: All individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection.
Beneficence: Researchers should maximize possible benefits and minimize possible harm.
Justice: All persons should be treated equally, and the selection of research subjects should be scrutinized so that no one is systematically selected on the basis of race, ethnicity, class or other factors.
The last of the Belmont Report’s three basic ethical principles, justice, raises questions about who ought to receive the benefits of research and who ought to bear its burdens. Following a provocative discussion of equality and differential treatment, the Belmont Report considers the need to scrutinize whether some classes of people – economically disadvantaged, racial and ethnic minorities, or persons confined to institutions [such as prisons, mental health hospitals] – are systematically selected as research subjects due to their position or vulnerability rather than their connection to the problem being researched (Czubaruk, 2019).
Today, the principle of justice may demand scrutiny of whether classes of people considered compromised or vulnerable are excluded from participation in clinical trials due to financial and other barriers even though they have a connection to the problem being considered. The Report states that justice demands therapeutic devices and procedures developed from public funds must not provide advantages only to those who can afford them (Czubaruk, 2019).
The following section attributed to Maddock, 2019 with some minor adaptations & additions.
The Belmont Report addresses informed consent in particular as a necessary part of showing respect for all persons. It states that all subjects, to the degree that they are capable, should be given the opportunity to choose what shall or shall not happen to them.
According to the report, informed consent requires three elements:
- Comprehension and
Research subjects “must be given sufficient information about the research procedure, their purposes, risks and anticipated benefits and alternative procedures (where therapy is involved).” They should be given the opportunity to ask questions and have the right to withdraw from the research at any time.
The Belmont Report makes limited exceptions about informing research subjects. For example, in some clinical trials to test the effectiveness of a new medication some research subjects might be given the new drug being tested in the form of a pill while other research subjects might be given a pill that has no medical effect (also known as a placebo). If research subjects know which of the two pills they are receiving, they might be biased in their reporting of improvement of symptoms. If I know I am receiving the placebo pill, for example, I might be less likely to report any changes in my symptoms because I know I am not receiving a drug. Therefore, in an example like this, researchers would be allowed to withhold information from the research subject and not tell them if they were receiving the drug being tested or the placebo pill.
However, the Belmont Report is clear that researchers should never withhold information about risks for the purpose of getting a subject to cooperate.
The Belmont Report states that “the manner and context in which information is conveyed is as important as the information itself.” For instance, allowing too little time for the subject to consider the information could affect their ability to make an informed choice.
That means researchers need to consider a subject’s maturity, capacity for understanding, language and literacy when presenting information to obtain informed consent. In some cases, the report states, it may be appropriate to give oral or written tests of comprehension.
When a subject’s comprehension is severely limited due to age, disability or other factors, researchers need to seek the permission of other parties to protect them from harm.
Informed consent means there is no coercion or undue influence. In other words, researchers cannot threaten harm or offer an “excessive, unwarranted, inappropriate or improper reward” to obtain compliance (Maddock, 2019) .
That means researchers need to take special care when conducting clinical trials involving vulnerable people who are under the authority of someone else, such as inmates or people who are ill.
Other considerations involving informed consent
On the surface, informed consent seems like a straightforward concept. However, the evolution of clinical research and the introduction of new technologies continue to raise new questions about its application.
The Belmont Report remains a primary ethical framework for researchers today (Maddock, 2019).
Human Rights & Health
Human rights are “those rights which are inherent to the human being.” (OHCHR, 2013). The modern human rights movement developed after the Second World War and the adoption of the Universal Declaration of Human Rights in 1948, 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” (WHO, 2015).
|The Universal Declaration of Human Rights (UDHR) is a milestone document in the history of human rights. Drafted by representatives with different legal and cultural backgrounds from all regions of the world, the Declaration was proclaimed by the United Nations General Assembly in Paris on 10 December 1948 (General Assembly resolution 217 A) as a common standard of achievements for all peoples and all nations. It sets out, for the first time, fundamental human rights to be universally protected and it has been translated into over 500 languages. The UDHR is widely recognized as having inspired, and paved the way for, the adoption of more than seventy human rights treaties, applied today on a permanent basis at global and regional levels (all containing references to it in their preambles) (UN, n.d.). |
Article 25 of the declaration makes clear that health is a human right.
Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.
Motherhood and childhood are entitled to special care and assistance. All children, whether born in or out of wedlock, shall enjoy the same social protection.
Source: United Nations. (n.d.). Universal Declaration of Human Rights (1948). United Nations. https://www.un.org/en/about-us/universal-declaration-of-human-rights
Human rights encompass what are known as civil, cultural, economic, political and social rights. Governments have an affirmative obligation to respect, protect, and fulfil human rights. The obligation to respect human rights means that government must not interfere, directly or indirectly, with individuals’ enjoyment of human rights. The obligation to protect human rights means that government has a duty to prevent third parties from interfering with individuals’ enjoyment of human rights. And the obligation to fulfill human rights requires government to adopt appropriate legal, budgetary, and other measures to ensure that individuals’ human rights are fully realized (WHO, 2015).
Ethical 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 contagious 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 equality—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 (WHO, 2015).
What are human rights? How are they defined? Where did the notion of individual rights come from? Watch this excellent video on the history of human rights over the last decades. As you watch this introduction, think back to the colonial histories we learned about in the previous section. Also think back to our discussions about the social and structural determinants of health. Do you see any overlap in these histories and principles?
How can we consider the histories and concepts discussed in this video as structural or social determinants of health?
|Note to readers: The following series of three videos are longer than the video clips normally recommended in this textbook. For this reason, we have reduced the overall text in this section to encourage you to watch the following three discussions by Alicia Yamin, Human Rights Lawyer and Public Health scholar.|
Human rights are rights inherent to all human beings, whatever our nationality, place of residence, sex, national or ethnic origin, colour, religion, language, or any other status. We are all equally entitled to our human rights without discrimination. These rights are all interrelated, interdependent and indivisible.UN Office of the High Commissioner on Human Rights
The Beginning: the Health and Human Rights Movements
How can we understand health outcomes — such as maternal mortality — as an injustice, “deprivation of choice” (Yamin, 2017), a violation of an individual’s right to health?
How does framing health inequities as violations of human rights help us understand the causes of health outcomes and, therefore, solutions to health challenges in different ways?
Health and human rights are inextricably linked.Yamin, 2017
How does taking a human rights-based approach to achieving health equity around the world change our understanding of who is entitled to live a healthy life…and who is obligated to provide the conditions within which individuals can obtain their optimal level of health?
|The right to health is a fundamental part of our human rights and of our understanding of a life in dignity. The right to the enjoyment of the highest attainable standard of physical and mental health, to give it its full name, is not new. Internationally, it was first articulated in the 1946 Constitution of the World Health Organization (WHO), whose preamble defines health|
as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. The preamble further 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.”
The 1948 Universal Declaration of Human Rights also mentioned health as part of the right to an adequate standard of living (art. 25). The right to health was again recognized as a human right in the 1966 International
Covenant on Economic, Social and Cultural Rights.
Watch this video to understand when and how the relationship between health and human rights became a global conversation and a way forward for activists to access necessary health care to achieve optimal health.
So what does this all mean in practice? Where do we see the notion of health as a human right in the global frameworks which dictate our health priorities? How can we operationalize health as a human right so that individuals and populations benefit from this framework in their everyday lives?
3. Video: Health, Human Rights and the Sustainable Development Agenda
Bringing it all together: Considering Public and Global Health issues through ethics and human rights
What are key ethical issues in Public Health?
(The following section adapted from WHO, 2015)
Both public health practice and policy raise diverse ethical 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 promoting the highest attainable standard of health.
Harm prevention, public good and individual liberty
Individuals have a right to privacy and to freedom of movement. 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 infectious disease control?
With the outbreak of severe acute respiratory syndrome (SARS) in 2002–2003, Ebola in 2014 and the COVID-19 pandemic, health officials around the world relied on strategies such as closing schools, cancelling social gatherings, and quarantining 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 in some cases — and in others, perhaps strategies were not strict enough.
Yet, where outcomes are uncertain and potentially catastrophic, 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, carried out humanely and limited to the immediate crisis at hand.
Treatment and prevention
Much 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 practical 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 attention to prevention may take away needed resources from treatment. Determining how to allocate scarce resources between prevention and treatment can therefore raise difficult 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 medication for the purpose of reducing the risk of transmission? What are the global obligations to meet the needs of nations facing these difficult trade-offs?
Health promotion and equity
Ill-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, drinking 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 of 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 surveillance
Public 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 surveillance 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 population. Supporters of this practice maintained that it was ethical 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 information 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.
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 confronting the emerging epidemic. Over the past decade, 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 ethics committee, as it would be considered ethically inappropriate 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 (WHO, 2015).
What are key ethical issues in Global Health today?
(The following section adapted from WHO, 2015)
Considerations of justice are central to global health.
While access to good health may be thought to be a vitally important ethical principle, it remains unavailable to most people.
Health in low-resource countries is often compromised by social determinants, such as poverty, malnutrition, poor education, unhealthy living conditions, and lack of access to 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”.
“Brain drain” refers to the international transfer of human capital resources, and it applies mainly to the migration of highly educated individuals from developing to developed countries. In lay usage, the term is generally used in a narrower sense and relates more specifically to the migration of engineers, physicians, scientists, and other very high-skilled professionals with university training, often between developed countries.Docquier, 2021
Health professionals trained in resource-poor countries are commonly recruited to work in wealthier countries, resulting in a severe shortage of healthcare workers in the former. This raises questions about the ethical acceptability of such recruitment and the incentives that might be used to discourage emigration. This is another case of a moral conflict – between the freedom to relocate and associate freely and the need to improve the health of some of the most vulnerable people.
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 different countries may hold different values or place different weights on common values. For example, some practices that are widely condemned by the international community, such as female genital mutilation or cutting (FGM/C), 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 international 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 provided 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 provided to participants or participating communities at the conclusion of a trial? (WHO, 2015).
As you can see there are rarely clear answers when it comes to Ethics, Public and Global Health. A number of balancing acts must be considered and few policy solutions will please every individual. Given that Public and Global Health by definition are concerned with populations, the fields tend to maintain a population focus — what is the best solution for the population? Which solution will benefit the most number of people? But even these frameworks will not always provide clear answers. Just because Public and Global health work on the population level, does it mean the fields are not concerned with the health and well-being of individuals? Certainly not!
Continuing to expose truths from history, learn from them and facilitate ongoing discussions about these difficult issues using an ethics and human rights framework are all part of our work as students and professionals in the fields of Public and Global Health.
How do we talk about Health and Human Rights in Global Health today?
As you learned in the video discussions above, the intersection of Health and Human Rights is articulated and ‘brought to life’ in a number of ways in the Sustainable Development Goals.
The principles articulated in the Universal Declaration of Human Rights (1948) and, think back to a previous reading in this course, the Alma Ata Declaration (1978) make Health as a Human Right a reality on paper. In practice, the inherent right to health that every human possesses is most often made ‘real’ through movements towards universal health coverage or UHC.
UHC is firmly based on the 1948 WHO Constitution, which declares health a fundamental human right and commits to ensuring the highest attainable level of health for all (WHO, 2021).
Universal Health Coverage means that all individuals and communities receive the health services they need without suffering financial hardship. It includes the full spectrum of essential, quality health services, from health promotion to prevention, treatment, rehabilitation, and palliative care across the life course.WHO, 2021
UHC strategies enable everyone to access the services that address the most significant causes of disease and death and ensures that the quality of those services is good enough to improve the health of the people who receive them.
Protecting people from the financial consequences of paying for health services out of their own pockets reduces the risk that people will be pushed into poverty because unexpected illness requires them to use up their life savings, sell assets, or borrow – destroying their futures and often those of their children.
Achieving UHC is one of the targets the nations of the world set when adopting the SDGs in 2015. Countries reaffirmed this commitment at the United Nations General Assembly High Level Meeting on UHC in 2019. Countries that progress towards UHC will make progress towards the other health-related targets, and towards the other goals. Good health allows children to learn and adults to earn, helps people escape from poverty, and provides the basis for long-term economic development (WHO, 2021).
We will go into more detail about UHC and what that means for health systems in practice in a future section.
That concludes our discussion of Ethics & Human Rights in Global Health. As with all of the sections of this text, we have just scratched the surface — there is so much more to say and discuss on this broad and deep topic!
Mostly, we want you to take away from this section that Ethics and Human Rights in Public and Global Health have rich histories to be celebrated, but also deeply troubling and difficult histories which must be recognized, considered and righted through our work today. To ensure that as Global Health actors we contribute to global health equity and respect the inherent rights of all global citizens, ethics and human rights are essential to every part of our work.
Looking ahead to the future of Global Health research and practice, 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 conduct. Debates over access to new and expensive pharmaceuticals 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 [ever-evolving] ethics of health policy and practice (WHO, 2021).
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