Introduction to Public Health Ethics Delia Wolf, MD, JD, MSCI Associate Dean, Regulatory Affairs and Regulatory Compliance Lecturer, Health Policy and Management Harvard School of Public Health KAU-Public Health Ethics Course May 5, 2015

Outline Review of medical ethics principles Implications for research Why public health ethics Medical vs public health ethics Core questions of public health ethics Ethical frameworks for analysis of ethical issues in public health research and practice Points to consider – case studies

Principles of Medical Ethics - Review Autonomy Respecting the autonomous choices of persons Nonmaleficence Do no harm - avoiding the causation of harm Beneficence Do good - providing benefits Justice Fair distribution of benefits, risks and cost 3

Autonomy Right to choose Right to accept or decline information requires decision making capacity, but lack of capacity should be proven, not assumed Free of coercion and undue influence Right to accept or decline information Disclosure Understanding Voluntariness Decision making capacity for children - Research involving children – assent – mere lack of objection is not sufficient Cognitively impaired adult Allow sufficient time. Too little time for consideration or curtail opportunities for questioning may adversely affect a subject’s ability to make an informed choice. Adapt the presentation of the information to the subject’s capacities, because each subject’s ability to under understand is a function of intelligence, rationality, maturity and language. Investigators are responsible for ascertaining that the subject has comprehended the information. Special attention should be given when subjects’ comprehension is severely limited by conditions of immaturity or mental disability (i.e., infants and young children, mentally disabled patients, the terminally ill and the comatose). Free of coercion and undue influence – coercion occurs when an obvious threat of harm is intentionally presented by one person to another in order to obtain consent; undue influence, by contrast, occurs through reward or other overture in order to obtain consent. Also, inducement that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable. 4

Nonmaleficence & Beneficence Not to cause harm Beneficence To prevent harm To remove harm To do or promote good In research settings - to prevent breach of confidentiality - computer encryption; privacy – places for obtaining consent, recruitment To ensure safety – DSMB – stopping rules in the protocol To prevent social harm, legal harm, financial harm To promote good – risk benefit ratio much be favorable – whether the risks of research are reasonable in terms of what might be gained by he individual or society. Clinical equipoise - "Clinical equipoise is the assumption that there is not one 'better' intervention present (for either the control or experimental group) during the design of a randomized controlled trial (RCT). A true state of equipoise exists when one has no good basis for a choice between two or more care options. The ethics of clinical research requires equipoise--a state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial. Should the investigator discover that one treatment is of superior therapeutic merit, he or she is ethically obliged to offer that treatment. The current understanding of this requirement, which entails that the investigator have no "treatment preference" throughout the course of the trial, presents nearly insuperable obstacles to the ethical commencement or completion of a controlled trial and may also contribute to the termination of trials because of the failure to enroll enough patients. 5

Justice Fairness in distribution To each person an equal share To each person according to individual need To each person according to individual effort To each person according to contribution To each person according to merit The principle of justice refers to a fair, equitable, and appropriate treatment in light of what is due or owed to persons. Standards of justice are needed whenever persons are due benefits or burdens. A holder of a valid claim based in justice has a right, and therefore is due something. An injustice thus involves a wrongful act or omission that denies people benefits to which they have a right or distributes burdens unfairly. Philosophers and others have proposed each of the following principles as a valid material principle of distributive justice: 6

Implications for Research It is important to distinguish between medical research and medical practice because all research activities are required to under review and approval for the protection of human subjects. The term “practice” refers to interventions that are designed solely to enhance the well being of an individual patient and have a reasonable expectation of success. The purpose of medical practice is to provide diagnosis, preventive treatment or therapy to particular individual; by contrast, the term “research” designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge. The obligations of beneficence in research affect both individual investigators and society at large, because they extend both to particular projects and to the entire enterprise of research. In the case of particular projects, investigators are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research. In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures. 7

Why Public Health Ethics? Recent public health events/threats, such as the SARS, swine flu outbreaks, and resistant strains of TB (XDR-TB) Developing technology, such as new vaccines Growing obesity problem Ongoing disparities in health globally To answer questions such as How to balance individual rights versus protection of community health? How do we decide which conditions/diseases to screen for (priority setting)? How to decide when harm has occurred or may occur? On November 16, 2002, an outbreak of what is believed to be severe acute respiratory syndrome (SARS), began in the Guangdong province of China. The first case of infection was speculated to be a farmer in Foshan County. The People's Republic of China (PRC) notified the World Health Organization (WHO) about this outbreak on February 10, reporting 305 cases (including 105 health-care workers) and 5 deaths; it was later reported that the outbreak in Guangdong had peaked in mid-February, but that appears to be false, as later 806 infections and 34 deaths were reported. The 2009 flu pandemic in the United States was a pandemic experienced in the United States of a novel strain of the Influenza A/H1N1 virus, commonly referred to as 'swine flu', that began in the spring of 2009. The virus had spread to the US from an outbreak in Mexico. As of mid-March 2010, the U.S. Centers for Disease Control and Prevention (CDC) estimated that about 59 million Americans contracted the H1N1 virus, 265,000 were hospitalized as a result, and 12,000 died. Extensively drug-resistant tuberculosis (XDR-TB) is a form of tuberculosis caused by bacteria that are resistant to some of the most effective anti-TB drugs. XDR-TB strains have arisen after the mismanagement of individuals with multidrug-resistant TB (MDR-TB).

Case #1 – TB Victim Daniels contracted tuberculosis in Russian and returned to Arizona in the US to seek better healthcare. He refused to comply with public health authorities'’ orders to wear a mask to prevent the spread of respiratory secretions in public. When public health authorities were made aware of Daniels’ case, he was subsequently detained under a court order and place in a prison cell where he was denied access to communication technologies and kept under video surveillance and bright lights for 24 hours/day. His case drew the attention of civil liberties activists, who regarded this detention as a violation of basic civil rights How to manage individuals, who are infected with an infectious disease in order to protect the population.

Case #2 – MDR/XDR-TB cases It was evident that multiple and extensive drug-resistant tuberculosis is extensively endemic in South Africa. In order to contain the epidemic, health authorities have used hospital-based treatment, including mandatory detention. Non-compliance has occurred – patients escaping from hospital treatment and living in the community while still infectious. South African police have been used to search for those patients and return them to hospital against their will.

Case #3 – Obesity Surveillance A Body Mass Index (BMI) surveillance program will be implemented by public health nurses in a representative sample of elementary school (children aged 5 – 11 years). Passive (opt out) consent (with forms mailed to children’s homes) will provide robust and representative population-level statistics and contribute to the development of evidence-based public health programs and policy. Given the growing obesity problem in children and adults – and apparent link between obesity and illness – the need for more research and surveillance regarding obesity can presumably be justified. The questions are (1) whether such surveillance should be conducted at elementary schools and, if so, (2) the conditions under which such surveillance should be conducted. An important purpose of surveillance is to identify the prevalence of diseases and/or risk factors. When surveillance reveals that such rates are sufficiently high, public health authorities and policy makers can tack action to respond to them. Assuming that data regarding obesity prevalence rates in young children will provide useful information, the surveillance program described could have important benefits. The fact that a surveillance program might have benefits, however, does not automatically mean that it should be implemented. We must also consider the harms that might result from any surveillance program and determine whether the benefits outweigh the harms. A possible harm regarding the surveillance program is that it could lead to stigmatization of children. Maintaining confidentiality of surveillance results would be feasible and would provide one way of reducing stigmatization.

Medical vs. Public Health Ethics Medical Ethics Public Health Ethics Focuses on respect individual patient/subject and his/her right to choose Focuses on promoting population benefit Prevent harm, do good for each patient/subject Pursuit collective or common/public goods Fair distribution of benefits, risks and cost – what is due or owed to individuals/group Promoting equity at the population level – how does the intervention affect the overall burden of health and illness in society How is public health ethics different from bioethics/medical ethics? The well-know framework requires weighing and balancing considerations the principles of respect for persons, beneficence and nonmaleficence. These principles apply primarily in terms of interactions between individuals - doctor-patient, researcher-subject. The justice principle does require the integration of the views of the broader community. Public health ethics focuses more on issues related to the interaction of individuals and communities, reflecting on collective responsibilities and common goods. It is important to note that there is significant overlap between the values of public health and those of medical ethics. What helps to distinguish public health ethics is that they go beyond the level of individuals and require collective interventions that aim to promote and protect the health of the public. Thus, public health ethics is distinct from medical ethics in the modes of emphasis that are discussed in the next slide 12

Distinctiveness of Public Health Ethics Focus on population As opposed to an individual patient/subject Focus on systems of practice As opposed to individual decision making Inherently multi-dimensional As opposed to a particular medical specialty/healthcare professional Future and preventive orientation As opposed to current needs for treatment

Core Questions of Public Health Ethics What are the goals of public health? How to adjudicate between individual rights and freedoms on the one hand, and protecting and promoting the public’s health (common goods) on the other. In other words, the extent to which it is right to interfere with someone else’s liberty in order to protect them and/or others from harm?

Characteristics of Common Goods Indivisible Community/public as a whole (i.e., clean air) Non-excludable Open to being enjoyed by all Cooperation dependent Requires cooperation from multiple parties

Ethical Frameworks Many operational frameworks have been proposed for the analysis of ethical issues in public health practice and research Childress et al. enumerate five considerations: Effectiveness Proportionality Necessity Least infringement Public justification For public health ethics to contribute to applied public health policy and practice, it much be understand as a type of applied ethics and relevant to the concerns that arise therein. Frameworks can be useful because they attempt to capture what is relevant to ethical reflection in a particular area of practice and research. They help to simplify and make explicit factors relevant to a decision. However, they can also be problematic if they are applied blindly. It it important that the framework be relevant to the particular area under discussion Proportionality: The principle of proportionality is the idea that an action should not be more severe than is necessary, especially in a war or when punishing someone for a crime The infringement selected must be the least possible infringement, corresponding with achieving the primary goal of the action

Ethical Frameworks (cont.) Upshur’s four principles to guide the justification of public health intervention: Harm principle – it is applicable when predictable harm is likely to occur for individuals with infectious diseases, who are untreated may pose harm to communities Least Restrictive Means – education and facilitation are preferred to interdiction and incarceration Reciprocity – if restrictive measures are invoked, assistance and protections must be provided to those who are restricted/detained Discourse ethics –representation of those to be restricted Ross Upshur proposed the following four principles to guide the justification of public health intervention in the course of health protection activities: When harm principle is satisfied, indicating the possible need for restrictive measures

Points to Consider Identify the key public health ethics issues presented in the case and why they are public health ethics issues Identify the key relevant information (i.e., biological, economic, social, cultural, political, or ethical) Assess knowledge gaps (i.e., what information is useful to know), as well as the basis for these facts Identify the key stakeholders in the case and the most appropriate decision makers and or government authorities to approach the ethical issue, if applicable

Points to Consider (cont.) Identify the key values and concerns of the identified stakeholders and any potential risks and benefits Identify the options available to the decision maker, including reasonable alternatives courses of action, and consideration of implications and the potential intended and unintended outcomes, and Suggest a resolution of decision to the case by choosing the supported option, and justify this decision

Case # 4 – Outdoor Smoke-free Policies Municipalities are increasingly prohibiting smoking in parks and other outdoor public spaces. Smoke-free spaces are primarily justified on the basis of three goals: (1) reducing exposure to secondhand smoke; (2) encouraging people to quit smoking, and (3) preventing youth smoking initiation. Does evidence demonstrate that such bans effectively, equitably and ethically accomplish these goals?