Research and Patient Care in Public Health Emergency
WHO Training Manual Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care Learning Objective 1.3 Demonstrate understanding of the ethical principles and requirements addressed in current normative instruments relative to research and surveillance in emergencies Outline 1. Introduction to research ethics guidelines 2. Reading and discussion
3. Presentation of main ethical issues in mainstream research ethics instruments 4. Summary/Conclusion Suggested 0-15 (15 min) time Activity L.O. 1.3 16-35 (20 min)
Slide presentation on ethics guidelines Discussion and conclusion Introduction Research during emergencies can help public health practitioners assess both the impact of an emergency and what is needed to mitigate this impact.
Additionally research can help public health practitioners to better plan for future interventions. Human subject research conducted during emergencies must meet some of the ethical standards that guide the conduct of research under more mundane circumstances. The field that explores the ethical issues encountered during research is known as research ethics (Resnik and JD 2012). L.O. 1.3 Benchmarks in the history of research ethics 1. The Nuremberg trials and Nuremberg Code (1947) 2. World Medical Association Declaration of Helsinki (1964)
3. The Belmont Report (1979) 4. Council for International Organizations of Medical Science (CIOMS) Guidelines (2002) 5. US Code of Federal Regulations (Department of health and human services 1991) Public Welfare, Part 46 (Protection of Human Subjects) 6. Tri-Council Policy Statement (TCPS, 1998) L.O. 1.3 Reading Emanuel, EJ, D Wendler and C Grady. 2000. What Makes Clinical Research Ethical? JAMA: The Journal of the American Medical Association, 283(20):2701-2711.
Emanuel EJ, D Wendler, J Killen and C Grady. 2004. What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research. The Journal of Infectious Diseases, 189(5):930-937. L.O. 1.3 Discussion on reading Identify: main ethical issue/principle discussed examples of the application of these principles to their current practice
L.O. 1.3 Ethical principles and requirements What are the main ethical issues and requirements in mainstream research ethics instruments? L.O. 1.3 Autonomy Duty to respect persons ability to make decisions regarding issues related to their health and their body (if competent to make such decisions) . Also refers to duty to protect individuals with impaired
or diminished autonomy. E.g. Obtaining informed consents from those affected by an emergency before identifiable personal information and/or biological samples are collected and processed for research purpose. L.O. 1.3 Informed consent Process whereby a potential research participant decides whether they wants to participate in proposed study after receiving information. Requirements for consent vary across guidelines and regulations. Generally, decisions need to be made free from coercion by a
competent person who can understand the information given and appreciate the associated risks. Information ought to be in a language and a format suitable to the participants ability to comprehend it. E.g. Obtaining informed consent from those affected by the emergency before their identifiable personal information and/or biological samples are being collected and processed for research purpose. L.O. 1.3 Beneficence Moral duty to pursue actions that promote the wellbeing of others, and ethical obligation to maximize benefit and to minimize harm
E.g. To benefit from and have access to the vaccines in case of a pandemic L.O. 1.3 Non-maleficence Moral duty not to cause harm to others through interventions. E.g. Vaccine trials should involve the smallest number of human subjects and the smallest number of tests on these subjects that will ensure scientifically valid data L.O. 1.3
Justice In research ethics refers primarily to distributive justice - equitable distribution of benefits and burdens, (i.e. a distribution such that no segment of the population is unduly burdened by harms of research or denied benefits of knowledge generated from it.) E.g. Collecting samples from citizens of a developing country affected by a pandemic to develop a vaccine rapidly and ensure that the vaccine is made fairly available locally. L.O. 1.3
Vulnerability Status in which some persons may struggle to protect their interests or be at higher risk of being exploited. Normally linked to specific physical, financial, educational, or social circumstances. Who is considered as vulnerable varies across guidelines, but children, the mentally-retarded, the handicapped, prisoners, refugees, terminally-ill patients, and women are often cited. E.g. Targeting women and children in surveillance during emergencies without epidemiological or methodological justification
L.O. 1.3 Privacy Right or expectation not to be interfered with, to be free from surveillance, or, more generally, a moral right to be left alone. Concerned with the setting within which the persons health-related information is acquired. E.g. Taking precautions to interview victims of a public health emergency in private places (i.e. where those not related to the study cannot see or hear them). L.O. 1.3
Confidentiality Principle that ensures identifiable information is kept out of reach of others. All identifiable information about individuals (e.g. recorded (written, computerized, visual, audio) or simply held in the memory of health professionals) subject to the duty of confidentiality. E.g. Ensuring identifiable data from surveillance activities are secured and not accessible by irrelevant persons (e.g. locked in filing cabinets, or in encrypted files). L.O. 1.3
Research ethics review Process by which a group of experts in research, ethics and other disciplines decide whether a research protocol fulfils ethical standards of research before being undertaken. E.g. Obtaining ethical approval for public health activities that involve collection of identifiable information about alive and/or dead people used for further public health interventions and preparedness L.O. 1.3
Case Study Case study 1: Meningitis in Nigeria (see also Murray (2007), Boseley & Smith (2010), Mdecins sans Frontires (2011), Okonta (2014), and Nyika (undated)) L.O. 1.3 Summary Research and surveillance are integral and crucial to public health interventions and during emergencies Ethical concerns are addressed by national and international guidelines with varying areas of emphasis
Core ethical principles remain essential Disagreement and controversy exist about guidance on some topics (e.g. use of placebo, including vulnerable groups) In public health emergencies there are issues related to lack of agreement on which of the public health interventions during emergencies are to be considered research that should have ethical approval before being undertaken L.O. 1.3 References Emanuel, E.J., Wendler, D., & Grady, C. 2000. What Makes Clinical Research Ethical? JAMA: The Journal of the American Medical Association, 283, (20)
2701-2711 available from: http://jama.ama-assn.org/cgi/content/abstract/283/20/2701 E.Emanuel E. J, David Wendler, Jack Killen, & Christine Grady. What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research. The Journal of Infectious Diseases 189, 930-937. 2004. Resnik, D.B. & JD, P.D. 2012. Research Ethics Timeline (1932-Present). The National Institute of Environmental Health Sciences L.O. 1.3 Acknowledgements Chapter author
Hussein, Ghaiath, School of Health and Population Science, University of Birmingham, Birmingham, United Kingdom L.O. 1.3
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