Article 19
When novel compounds are first administered to humans or when no rescue therapy is available, studies involving healthy volunteers should only be started during pandemics if space in Intensive Care Units is assured for the needs of healthy volunteers and all patients in routine care.
Under pressure to develop vaccines and treatments at significant speed, the involvement of healthy volunteers can raise serious ethical concerns during pandemics. The PREPARED app includes a detailed case study on this topic. For the PREPARED Code, a generic recommendation was included, independent of type of clinical study, namely that access to intensive care units must be ensured.
Related PREPARED Publication:
COVID-19 human challenge trials and randomized controlled trials: lessons for the next pandemic
