WHO has published Ethical considerations for use of unregistered interventions for Ebola viral disease (EVD). Excerpt:
In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.
Ethical criteria must guide the provision of such interventions. These include transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community.
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).
The group explored how the use of these interventions can be evaluated scientifically to ensure timely and accurate information about the safety and efficacy of these investigational interventions.
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. Ongoing evaluation should guide future interventions.
In addition to this advice, the panel identified areas that need more detailed analysis and discussion, such as:
• ethical ways to gather data while striving to provide optimal care under the prevailing circumstances;
• ethical criteria to prioritize the use of unregistered experimental therapies and vaccines;
• ethical criteria for achieving fair distribution in communities and among countries, in the face of a growing number of possible new interventions, none of which is likely to meet demand in the short term.