There is limited research on healthy volunteers’ perceptions of the risks of Phase I clinical trials.
In order to contribute empirically to long-standing ethical concerns about healthy volunteers’
involvement in drug development, it is crucial to assess how these participants
understand trial risks. The objectives of this study were to investigate (1) participants’ views
of the overall risks of Phase I trials, (2) their views of the risk of personally being harmed in a
trial, and (3) how risk perceptions vary across participants’ clinical trial history and sociodemographic
characteristics.