THE World Health Organisation has issued ethical considerations for use of unregistered interventions for EVD. In a statement issued after a 12-man consultation panel discussion, yesterday, the organisation noted that although research efforts for drugs and vaccines for Ebola virus disease have shown promising results in the laboratory, they have not yet been evaluated for safety and efficacy in human beings.
“The large number of people affected by the 2014 West Africa outbreak, and the high case-fatality rate, has prompted calls to use investigational medical interventions to try to save the lives of patients and to curb the epidemic,” the panel noted.
The panel that was mandated to consider and assess the ethical implications for clinical decision-making of the potential use of unregistered interventions reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention. It said ethical criteria such as transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community, must guide the provision of such interventions.
In order to understand the safety and efficacy of these interventions, the group advised that, if and when they are used to treat patients, there is a moral obligation to collect and share all data generated, including from treatments provided for ‘compassionate use’ (access to an unapproved drug outside of a clinical trial).
There was unanimous agreement that there is a moral duty to also evaluate these interventions (for treatment or prevention) in the best possible clinical trials under the circumstances in order to definitively prove their safety and efficacy or provide evidence to stop their utilization. It added that ongoing evaluation should guide future interventions.