WHO Training Manual Ethics in epidemics,
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WHO Training Manual Ethics in epidemics, emergencies and disasters: research, surveillance and patient care Core competence 4 Ability to identify conflict between the common good and individual autonomy in research and clinical trials
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01
WHO Training Manual
Ethics in epidemics, emergencies
and disasters:
research, surveillance and patient care<br>
Ethics in epidemics, emergencies
and disasters:
research, surveillance and patient care<br>
02
Core competence 4
Ability to identify conflict between the common good and individual autonomy in research and clinical trials during emergency response<br>
Ability to identify conflict between the common good and individual autonomy in research and clinical trials during emergency response<br>
03
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.<br>
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.<br>
04
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?”<br>
“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?”<br>
05
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<br>
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<br>
06
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<br>
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<br>
07
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<br>
They can be used to assess whether the balance of expected harm and benefit is correct<br>
08
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<br>
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<br>
09
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<br>
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<br>
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<br>
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<br>
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)<br>
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)<br>
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<br>
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<br>
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<br>
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<br>
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<br>
Observational epidemiological research projects
Urgent intervention without time to seek consent, or where patient unable to consent<br>
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:<br>
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:<br>
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.<br>
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.<br>
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<br>
Therapeutic misconceptions
Monetary incentives
Availability of medicines
Quest for relations of trust, community
Concerns with power differentials
Concerns with exchange and fairness<br>
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<br>
In traditional communities, the informed consent process mandated by international research ethics guidelines may be foreign to local traditions<br>
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<br>
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<br>
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<br>
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<br>
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<br>
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<br>
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<br>
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<br>
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 2010. http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/National
Institute of Dental and Craniofacial Research (NIDCR) Minimal Risk Protocol Template (last updated July 2013) http://www.nidcr.nih.gov/Research/ToolsforResearchers/Toolkit/MinimalRiskProtocolTemplate.htm
Murray S. (2007). Anger at deadly Nigerian drug trials. BBC news website, 20.06.2007. http://news.bbc.co.uk/2/hi/africa/6768799.stm accessed 12 September 2014)
Bosely S, Smith D. (2010). As doctors fought to save lives, Pfizer flew in drug trial team. The Guardian, 9.12.2010. http://www.theguardian.com/business/2010/dec/09/doctors-fought-save-lives-pfizer-drug accessed 12 September 2014)<br>
Institute of Dental and Craniofacial Research (NIDCR) Minimal Risk Protocol Template (last updated July 2013) http://www.nidcr.nih.gov/Research/ToolsforResearchers/Toolkit/MinimalRiskProtocolTemplate.htm
Murray S. (2007). Anger at deadly Nigerian drug trials. BBC news website, 20.06.2007. http://news.bbc.co.uk/2/hi/africa/6768799.stm accessed 12 September 2014)
Bosely S, Smith D. (2010). As doctors fought to save lives, Pfizer flew in drug trial team. The Guardian, 9.12.2010. http://www.theguardian.com/business/2010/dec/09/doctors-fought-save-lives-pfizer-drug accessed 12 September 2014)<br>