Enhancing Research Ethics in Public Health Emergencies
Explore the shortcomings of current ethical instruments in emergency situations, evaluate alternative proposals, review historical benchmarks in research ethics, and delve into core ethical principles. Engage with case studies like Meningitis in Nigeria to understand the application of ethical guidelines in real-life scenarios.
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WHO Training Manual Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care Learning Objective 1.4 Identify the shortcomings of current normative instruments for use in emergency situations, and evaluate alternatives
Outline 1. Review Learning Objective 1.3 research ethics guidelines and ethical principles 2. Case Study Group Activity: Reading & Group Discussion 3. Presentation Shortcomings of current normative instruments and alternative proposals 4. Exercise: Draft Framework of Research Ethics Standards for Public Health Emergencies 5. Summary/Conclusion 0-5 min (5 min) 6-10 min (5 min) 11-30 min (20 min) 31-40 min (10 min) 41-55 min (15 min) 56-70 min (15 min) 71-85 min (15 min) 86-110 min (25 min) 111-120 min (10 min) Suggested time Reading Group discussion Review of LO 1.3 Probing questions Reading and case study discussion Reporting back Writing Activity Slide presentation Summary and conclusion L.O. 1.4
Review of Learning Objective 1.4 Research ethics guidelines cover major ethical issues. Most guidelines developed with clinical research in mind adequate resources, stability, time Public health emergencies are disruptive with urgency But research and surveillance are integral and crucial to public health interventions and during emergencies. Urgency should not bypass/ignore key ethical principles, however traditional research ethics guidelines may have shortcomings in these contexts L.O. 1.4
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. 1.4
Core ethical principles 1. Respect for people s autonomy 2. Informed consent 3. Beneficence 4. Non-maleficence 5. Justice 6. Vulnerability 7. Privacy 8. Confidentiality 9. Research ethics review L.O. 1.4 5
Case Study Case study 1: Meningitis in Nigeria (see also Murray (2007), Boseley & Smith (2010), M decins sans Fronti res (2011), Okonta (2014), and Nyika (undated)) Divide into small groups 20 minutes reading Discuss the case in small groups Each group shares their reflections L.O. 1.4
Case Study Discussion Case Questions: 1. Use one of the research ethics guidelines or regulations introduced in LO 1.3, discuss three of the main ethical issues that you identified in the case study, focusing on whether you found your research ethics instrument helpful in deciding whether you should approve this study. 2. If you found gaps or shortcomings to your research ethics instrument, describe these shortcomings and discuss with your colleagues at least one suggestion to overcome each one of them. L.O. 1.4
Shortcomings of current normative instruments 1. Altered perceptions of ethical issues Altered perception of risk may accept higher levels of risk Informed consent vulnerability, altered circumstances 2. Roles and relationships Traditionally refers to doctor-patient type relationship In emergencies: doctors, researchers, volunteers Differing professional standards and regulations What counts as research? (therefore who counts as a researcher?) L.O. 1.4
Shortcomings of current normative instruments 3. Research integrity and conflicts of interest Conflicts of interest Relations between researcher and pharmaceutical companies Principles of accountability, integrity, and transparency 4. Research ethics review Traditionally a long process L.O. 1.4
Evaluating alternative proposals WHO Technical Consultation Group report on Research Ethics in International Epidemic Response (2009) 1. Distinguish crucial from non-crucial tasks to lessen burden on research oversight system 2. Proportional review (e.g. pair level of scrutiny with level of risk) 3. Fast track reviews (not at expense of ethical principles) 4. Pre-emergency repository of study protocols 5. Wiki-like platform to store and articulate best practices 6. Rolling/contemporaneous reviews of protocols (parts of protocols approved while other parts modified in real time, remain conditional to supervision and re-approval later) L.O. 1.4
Reading Exercise Read pp. 13/14 WHO Technical Consultation meeting report on the Research Ethics in International Epidemic Response (available at: http://www.who.int/ethics/gip_research_ethics_.pdf) Read the text Share your reflections Draft a framework of ethical standards for the conduct of research during public health emergencies that would be particularly relevant to your affiliated institution L.O. 1.4
Summary/Conclusion Public health emergencies is significantly different from conditions under which research usually occurs Mainstream frames of reference may be unable to offer useful guidance/be feasible during emergencies Shortcomings of mainstream research ethics guidelines: Mainly address ethical issues in a clinical research setting, where the researcher is the healthcare provider. Propose ethics review model that requires resources and time that may not be available Do not address factors that could influence research participants freedom from coercion and undue influences in the context of a public health emergency Alternatives adaptations to process may be necessary L.O. 1.4
Sources WHO Technical Consultation Group 2009, Research Ethics in International Epidemic Response. MEETING REPORT, World Health Organization, Geneva, Switzerland. The following case is suggested: The Trovan trial case study: after profits or to save lives? (Source: http://www.slideserve.com/bluma/the-trovan-trial-case- study-after-profits-or-to-save-lives-available-at-amanet- trust, Author: Aceme Nyika) See also: Okonta, Patrick I. "Ethics of clinical trials in Nigeria." Nigerian Medical Journal 55.3 (2014): 188. doi: 10.4103/0300-1652.132035 L.O. 1.4
Acknowledgements Chapter author Hussein, Ghaiath, School of Health and Population Science, University of Birmingham, Birmingham, United Kingdom L.O. 1.4
