WHO Training Manual Ethics in epidemics,

Transcript:WHO Training Manual Ethics in epidemics,:
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 during emergency response 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. 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?” 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 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 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 Ethical concepts and principles Autonomy – respect for