Ethical Frameworks in Health: Medical Care, Public Health, and Research Ethics

WHO Training Manual Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care Learning Objective 7.1 Distinguish between three distinct ethical frameworks: medical care ethics, public health ethics and research ethics, and explore the ways in which the values and principles that guide these frameworks diverge or overlap

Outline Introduction Table and discussion Video screening and discussion Case study and discussion Role play Summary and wrap up discussion Suggested time 0-5 (5 min) 6-25 (20 min) 26-45 (20 min) 46-75 (30 min) 76-95 (20 min) 96-105 (10 min) Template and discussion Video and group discussion Case study and discussion Summary and conclusion Introduction Role-play Activity L.O. 7.1

Introduction Medical care - health professionals hope to apply existing knowledge to benefit an individual patient Public health activities - knowledge applied/collected to benefit communities (even, sometimes, overriding the interests and liberties of individuals) Research - generates new generalizable knowledge to promote greater good of individuals who may not yet be affected by a condition or issue (research knowledge can be applied to medical care and public health activities) Each activity will have different ethical frameworks L.O. 7.1

Medical care ethics Individual emphasis Focuses on patient autonomy and best interest Patient-focused values Promoting cure and treatment of existing health conditions Justice and duties to others, including public good, are never far away L.O. 7.1

Public health ethics Measures designed to protect and enhance health of public and prevent ill-health Emphasizes greater good of a population or community and pursuit of collective action May be tension between duty to place rights and needs of individuals above those of society Since public is comprised of individuals, public health initiatives can result in benefits for individuals too L.O. 7.1

Research ethics Goal is producing evidence to advance greater good, including for individuals not yet affected by a condition/issue Points to the primary value of the human person and focuses largely on constraining the use of individuals as means for the pursuit of collective scientific or technological ends (Kenny and Giacomini 2005) L.O. 7.1

Use of ethical frameworks Context will dictate which framework should prevail But ethical obligations of other frameworks may still apply e.g. individual informed consent in research, anonymizing data collected through public health surveillance Aims and ethical obligations of a role need to be set out clearly. To whom is the duty of care owed? Multiple allegiances can be a challenge e.g. clinician also performing research in public health emergency L.O. 7.1

Table Areas of divergence and overlap between three distinct ethics frameworks Responsibilities Principles Practices Medical care ethics Public health service ethics Research ethics To whom duty of care is owed Aims of intervention Role of informed consent Issues of confidentiality & privacy Meaning of fairness & equity L.O. 7.1

Video Disaster Ethics: The Collision between Public Health Ethics and Clinical Ethics https://www.youtube.com/watch?v=JYYAGJB5t4E L.O. 7.1

Discussion Is it possible to promote the values of clinical medical ethics in public health interventions and research projects? What values ought to be promoted in clinical contexts? Public health contexts? Research contexts? Can these harmonize when more than one type of intervention is being applied at one time? Which framework has moral authority to inform ethical action in contexts where more than one framework is applied? Which one ought to prevail in public health emergencies, or can they be nested or applied to different aspects or dimensions of the issues or problems at stake? What liberties, if any, will have to be infringed upon in a public health context? L.O. 7.1

Case study A TB outbreak among the urban homeless McDougall C. (2010). Ethical questions during a pandemic: case studies. National Collaborating Centre for Healthy Public Policy. http://www.ncchpp.ca/docs/Ethics_CaseStudies_EN.pdf L.O. 7.1

Case study There is an on-going tuberculosis (TB) outbreak in the homeless population of a large city in Canada. The city public health unit is focused on identifying those at risk using an outbreak management questionnaire. Those who have come into contact with a TB case, or anyone who thinks they may be at risk, will be offered further investigative tests. Treatment will be given to those affected. However, there is an opportunity to collect additional data by adding a few questions to the questionnaire. Such data would be useful to understanding more about the lifestyle, behaviours and needs of this particular population. They are certainly at increased risk of this communicable disease, and this information may help prevent future transmission. L.O. 7.1

Case study It is argued by one of the team that it is not appropriate to take this proposed research to an REB at this time for the following reasons: the research is low risk; the participants can just refuse to answer the additional questions if they wish; and the preparation of a proposal and related materials to meet the requirements of the REB will take staff time away from actually managing the outbreak. In addition, it is argued that since this group is homeless, it will be almost impossible to find these same individuals in the future once REB approval is received. As a result, a failure to collect the data on this occasion may mean that the research could never be done. L.O. 7.1

Case study discussion What are the ethical issues raised by this scenario? Which of these different points or arguments do you think are the most convincing? One participant in the group suggests that the data should be collected now and Research Ethics Board (REB) approval sought at a later stage. What do you think of this option? Another suggestion is that incentives (e.g. cash) could be offered to those questioned during the outbreak to encourage them to keep in touch with the team until REB approval can be sought. Payment would then be made after the research was completed. What ethical issues would be relevant in such case? Finally, what ought to be done in this case? Give reasons for your answer. L.O. 7.1

Role play Participant A: clinician Participant B: patient with symptoms of TB How does Participant A obtain Participant B s informed consent for treatment? L.O. 7.1

Role play Participant C: clinician on public health team responsible for managing a severe TB outbreak Participant D: patient with symptoms of TB What role does informed consent play in the treatment of Participant D? L.O. 7.1

Role play Participant E: clinician on a public health team and researcher conducting a randomized controlled trial Participant F: patient with symptoms of TB Participant E is responsible for obtaining informed consent to administer the experimental intervention instead of the classic intervention to Participant F. What role does informed consent play in the treatment of Participant F? L.O. 7.1

Summary Significant differences in intentions, goals and practices between medical care, public health services and research Practitioners must be aware of these to act consistently with their specific duties Participants and patients should be informed of these differences L.O. 7.1

Sources Benatar S. (2006). Facing ethical challenges in rolling out antiretroviral treatment in resource-poor countries: comment on They call it patient-selection in Khayelitsha . Cambridge Quarterly of Healthcare Ethics, 15(3): 322-330. Kenny N, Giacomini M. (2005). Wanted: a new ethics field for health policy analysis. Health Care Analysis, 13(4), 247- 260. McDougall C. (2010). Ethical questions during a pandemic: case studies. National Collaborating Centre for Healthy Public Policy. http://www.ncchpp.ca/docs/Ethics_CaseStudies_EN.pdf Naylor D et al. (2003). Learning from SARS: renewal of public health in Canada. A report of the National Advisory Committee on SARS and Public Health. Health Canada Publications, 1210. http://www.phac-aspc.gc.ca/publicat/sars-sras/naylor/ Public Health Leadership Society. (2002). Principles of the ethical practice of public health [Poster]. http://phls.org/CMSuploads/PHLSposter-68526.pdf Schwartz L, Hunt M, Sinding, C, Elit L, Redwood-Campbell L, Adelson, N, de Laat S. (2012). Models for humanitarian health care ethics. Public Health Ethics, 5(1): 81-90. The Nuffield Council. (2007). Public Health: the ethical issues. http://www.nuffieldbioethics.org/public-health. Cambridge Publishers. The World Medical Association. (2013a). International Code of Medical Ethics. In Handbook of WMA policies. http://www.wma.net/en/30publications/10policies/HB-E_print_-2013-1.pdf The World Medical Association. (2013b). Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects. In Handbook of WMA policies. http://www.wma.net/en/30publications/10policies/HB-E_print_-2013-1.pdf Thomas JC. (2004). Public Health Ethics . School of Public Health, University of North Carolina at Chapel Hill. http://oce.sph.unc.edu/phethics/modules.htm Williams, JR. (2009). World Medical Association: medical ethics manual. Ferney-Voltaire Cedex: WMA. L.O. 7.1

Acknowledgements Chapter authors Gillespie, Leigh-Anne, Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada Schwartz, Lisa, Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada L.O. 7.1