1. World Health Organization
26 June, 2018
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
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2. Outline Introduction to research ethics guidelines
Reading and discussion
Presentation of main ethical issues in mainstream research ethics instruments
Summary/Conclusion
Suggested time
0-15
(15 min)
16-35
(20 min)
36-50
51-80
(30 min)
81-90
(10 min)
Activity
Introduction
Reading
Group discussion
Slide presentation on ethics guidelines
Discussion and conclusion
Please add the timeline provided in the L.O.
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3. 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).
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4. Benchmarks in the history of research ethics
The Nuremberg trials and Nuremberg Code (1947)
World Medical Association Declaration of Helsinki (1964)
The Belmont Report (1979)
Council for International Organizations of Medical Science (CIOMS) Guidelines (2002)
US Code of Federal Regulations (Department of health and human services 1991) Public Welfare, Part 46 (Protection of Human Subjects)
Tri-Council Policy Statement (TCPS, 1998)
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5. Reading
Emanuel, EJ, D Wendler and C Grady What Makes Clinical Research Ethical? JAMA: The Journal of the American Medical Association, 283(20):
Emanuel EJ, D Wendler, J Killen and C Grady What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research. The Journal of Infectious Diseases, 189(5):
each group 20 minutes to skim through their respective article and to identify
a) each of the main ethical issue/principle discussed and b) examples of the application of these principles to their current practice. (20 minutes)
The facilitator asks each group to share their insight. (15 minutes)
Hint for facilitator:As an example, ‘fair subject selection’ would correspond to the ethical principle of justice.
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6. Discussion on reading Identify: main ethical issue/principle discussed
examples of the application of these principles to their current practice

7. Ethical principles and requirements
What are the main ethical issues and requirements in mainstream research ethics instruments?
Maybe it would be good if references that Emanuel et al. uses could be mentioned on the slides. E.g. the Belmont report differs in its ethical principles compared with Beauchamp and Childress etc…
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8. Autonomy
Duty to respect person’s 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.

9. 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 participant’s 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.
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10. Beneficence
Moral duty to pursue actions that promote the well- being 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

11. 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
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12. 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.

13. 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
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14. 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 person’s 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).

15. 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).

16. 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

17. Case Study
Case study 1: Meningitis in Nigeria (see also Murray (2007), Boseley & Smith (2010), Médecins sans Frontières (2011), Okonta (2014), and Nyika (undated))
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18. 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
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19. References
Emanuel, E.J., Wendler, D., & Grady, C What Makes Clinical Research Ethical? JAMA: The Journal of the American Medical Association, 283, (20) available from: 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[5],
Resnik, D.B. & JD, P.D Research Ethics Timeline (1932-Present). The National Institute of Environmental Health Sciences
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20. Chapter author Acknowledgements
Hussein, Ghaiath, School of Health and Population Science, University of Birmingham, Birmingham, United Kingdom
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