1. World Health Organization
27 February, 2018
WHO Training Manual
Ethics in epidemics, emergencies
and disasters:
research, surveillance and patient care
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2. World Health Organization
27 February, 2018
Core competence 4
Ability to identify conflict between the common good and individual autonomy in research and clinical trials during emergency response 
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3. Corresponding learning objectives
Identify possible harm and benefit to individuals and communities resulting from conducting research in emergencies.
Discuss moral theories, and identify frameworks applicable to research in emergencies.
Explain the current norms under which a waiver of consent could be deemed acceptable for research in critical care settings, and assess when they could be applicable to research in emergencies.
Explain the processes required to improve informed consent to research in emergencies, with particular consideration of traditional communities and low- resource settings.

4. Ethical considerations for the conduct of research in public health emergencies
“What scientific standards, if any, are we willing to compromise in order to respond quickly to a public health emergency?”
“Who will bear the greatest risks associated with the use of unapproved treatments?”
“Which project has the greatest potential for positive results for people at risk in a public health emergency?”
“How do we decide who will receive first access to a newly developed, scarce treatment?”
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5. Potential benefits to individuals and communities of emergency research
Rapid access
Access to new and experimental drugs
A robust scientific evaluation remains important
Rapid access may depend on imaginative study design by researchers and regulators
Natural experiments and a lower threshold of evidence have been suggested
Better understanding of the condition
Causes, transmission of disease, best treatment
Improves medical outcomes and advances the development of new treatment
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6. Potential harms to individuals and communities of emergency research
Adverse effects
Care must be taken that research interventions are safe and not initiated too quickly, ignoring potentially significant risks in order to “get it out there”
Inefficiency
If the resources for care are reallocated to research, some patients may not receive the care they otherwise expected
Violation of rights
Overriding individual liberty
Unnecessary exposure to risk
If a study is poorly designed, more participants might have to be exposed to the intervention in order to detect an effect
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7. Ethical concepts and principles for the conduct of research in emergencies
Ethical principles can assist decision-makers by helping to ensure that they consider relevant values and commitments
They can be used to assess whether the balance of expected harm and benefit is correct
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8. Ethical concepts and principles
Autonomy – respect for individuals and their liberties
Concern for welfare – patients, participants, populations
Equity – fair access to health resources
Efficiency – use of resources to maximize desired outcome and minimize waste
Fair process – inclusive, accountable and informed decision process
Global justice – fair and responsible practices between communities
Reciprocity – relationship of corresponding mutual action
Social justice – fair and responsible practices

9. Ethical concepts and principles
Solidarity – mutual global fellowship
Transparency – honest and accessible information
Need for evidence
Least restrictive alternative
Proportionality
Minimally burdensome
Compensation
Due (legal) process—right of appeal
Democratic/transparent policy making
The idea here is that coercive measures (e.g., isolation/quarantine—or surveillance without consent) shouldn’t be used unless there is good reason to believe that they will be effective in achieving the public health goal in question. But, among other things, this raises questions about how much evidence is needed—and what should be done in (urgent) cases where evidence is lacking (e.g., in the case of a new pathogen for which there is limited information).
We should use the least restrictive measure necessary to achieve the public health goal in question. I.e., we should not resort to mandatory isolation/quarantine or surveillance without consent if voluntary measures would suffice (or be just as effective). This is from Siracusa Principles.
The idea here is that (because utility doesn’t trump autonomy/liberty/rights), we shouldn’t resort to coercion whenever this would have best (utility) outcome overall. We should only resort to coercion when the public health costs would otherwise be severe. But this raises the question of how great the utility stakes would need to be in order for coercion to be justified.
Such measures shouldn’t be used in a discriminatory manner. We should perhaps be most reluctant (in light of Rawls) to coerce (and thereby harm) those who are already worst off or especially vulnerable?
Analogous to 2, this might be called “the least harmful alternative”. The idea here is that those confined (for example) should be made comfortable and provided with basic necessities and so on. In the case of surveillance, we should minimize privacy violations as far as possible.
Perhaps those coerced should be compensated in return—as a matter of reciprocity. E.g. compensated for financial loss—or simply for having one’s liberty violated.
7 and 8 should be relatively obvious—but they raise questions about what the processes should be in practice—especially in conditions of urgency.
Should highlight how/that such a framework aims to strike a balance between values emphasised in slides 2-5—i.e., they aim to protect against severe public harms without riding roughshod over liberty/autonomy, equality, and rights. There are still many questions (to be discussed), however, about how these principles could or should actually be applied in practice.

10. Approaches to ethics in public policy
Utilitarianism—achieve the best outcome (in terms of aggregate human well-being—”utility”)
Libertarianism—respect individual liberty
Egalitarianism—promote equality (e.g., John Rawls, part of the “difference principle”: justice requires making those who are worst off as well off as possible)
Rights based theories—respect (human) rights
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11. Value Pluralism
Each of these approaches is presumably partly correct because the values they emphasize (utility, liberty, equality, rights) each matter.
But what should be done in cases when there is conflict between these values?
Presumably no one of these values should always trump all of the others (regardless of the degree to which the others are threatened)
R/e 3rd point, it should be noted that even international human rights law acknowledges that human rights might not always be absolute—e.g., see Siracusa Principles.

12. Value Pluralism
Whenever a given policy/action would maximally promote all of these values, then it is obvious what should be done.
In cases of conflict between these values, we should aim to “strike a balance” between them.
Accountability for Reasonableness Framework (Daniels) can provide guidance for fair decision- making

13. Waiver of consent in public health emergencies
Waiver of consent can be granted for research interventions under certain conditions
Usually limited to minimal risk studies
Can be granted to studies to develop evidence-based practice in emergency situations if research cannot be done any other way

14. Types of research where waiver may be applicable
Retrospective data collection
Observational epidemiological research projects
Urgent intervention without time to seek consent, or where patient unable to consent

15. When is waiver of consent permissible?
Article 3.7 The Research Ethics Board (REB) may approve research without requiring that the researcher obtain the participant’s consent … where the REB is satisfied, and documents, that all of the following apply:
the research involves no more than minimal risk to the participants;
the lack of the participant’s consent is unlikely to adversely affect the welfare of the participant;
it is impossible or impracticable to carry out the research and to answer the research question properly, given the research design, if the prior consent of the participant is required;
whenever possible and appropriate, after participation, or at a later time during the study, participants will be debriefed and provided with additional pertinent information …, at which point they will have the opportunity to refuse …; and
the research does not involve a therapeutic intervention, or other clinical or diagnostic interventions.
Canadian Tri-Council Policy Statement (TCPS2, 2010)
Departures from General Principles of Consent:

16. Application in public health emergencies
Slightly different in public health emergencies compared to public health research
The following criteria can be applied during emergencies to determine if a waiver of consent should be granted:
The relative risk is assessed as being at an acceptable level;
The research is judged to be of sufficient value to the affected community;
The research cannot be done any other way;
Consent will be sought if and when possible; and
The research ethics committee is independent of the proposed research.

17. Informed consent and traditional communities
Factors taken into consideration in decision to partake in research:
Therapeutic misconceptions
Monetary incentives
Availability of medicines
Quest for relations of trust, community
Concerns with power differentials
Concerns with exchange and fairness

18. Obtaining informed consent from traditional communities
Community consultation might be particularly appropriate when the main risk associated with a study applies to communities as a whole rather than to individual members
In traditional communities, the informed consent process mandated by international research ethics guidelines may be foreign to local traditions

19. Required processes for obtaining informed consent from traditional communities
Investigating cultural sensitivities before starting the study
Being attentive to the needs of the population and reconsidering the investigation if the context does not permit it to be carried out
Involving local staff and interpreters to ensure community and individual consultation
Strengthening community engagement as part of the research and involving communities in both writing protocols and the actual conduct of the research
Ensuring that individuals are not singled out and coerced to take part in the study without fully understanding the implications

20. Required processes for obtaining informed consent from traditional communities
Carefully considering the cultural norms of ethnic or social groups when designing approaches to informed consent
Respecting the decision of an individual by accepting refusal to consent
Avoiding any kind of psychological or economic pressure on individuals and the community
Considering community structures in making decisions

21. Required processes for obtaining informed consent from traditional communities
Populations living in low-resource settings may also be at particular risk of coercion and exploitation because of their limited ability to generate income
Researchers and aid agencies should therefore collaborate to ensure that
the basic needs for survival are met throughout the research project for all individuals, irrespective of their participation
the population has access to basic health care
the research team does not drain any health care resources for their study and thereby deprive the local population of such care

22. Conclusions Core Competence 4
Potential harms and benefits to individuals and communities have to be taken account when research is conducted (in emergency situations)
Ethical principles can assist decision-makers to balance expected harms and benefits
Utilitarianism, Libertarianism, Egalitarianism, or rights based theories are approaches to ethics in public health policy
Certain circumstances can lead to a waiver of consent in public health research, regarding emergency situations
When informed consent is taken from traditional research communities, community consultation might be particularly appropriate when the main risk associated with a study applies to communities as a whole rather than to individual members
Other factors should be taken into account when conducting a research project in traditional communities
Concerns about departures from normal review process
The challenge of departures from normal review processes is that they could possibly undermine the 11 important areas of research ethics review discussed in LO2.1. One source of concern is that variations in the review process of protocols could lead to the neglect of issues of exploitation. Because of their very nature, emergencies create vulnerability in certain individuals, while also exacerbating already-existing vulnerability of some social groups, such as may be the case with children, women, and impoverished communities and individuals (Sumathipala et al, 2010). Furthermore, health emergencies may deepen already existing disparities (both within societies and at the global level). It is important that variations to standard procedures of ethics review stay true to the goal of minimising exploitation.
Another aspect that must be considered is the possibility that variations to standard review might increase the risk for therapeutic misconception (see LO8.2). When research is combined with humanitarian aid or clinical care, there can be a lack of clarity as to whether the endeavour is part of routine care or is in fact part of research. This confusion might be particularly strong where the information provided to potential participants would be inadequate (e.g., no explicit mention of research, too much emphasis on a therapeutic intent of the project). The premise, then, is that even variations to standard procedures of ethics review ought to ensure that informed consent procedures should reduce the likelihood of participants mistaking research for therapeutic services.
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23. Sources
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), December eptc2/Default/National
Institute of Dental and Craniofacial Research (NIDCR) Minimal Risk Protocol Template (last updated July 2013) olTemplate.htm
Murray S. (2007). Anger at deadly Nigerian drug trials. BBC news website, accessed 12 September 2014)
Bosely S, Smith D. (2010). As doctors fought to save lives, Pfizer flew in drug trial team. The Guardian, pfizer-drug accessed 12 September 2014)