Because the possible outcomes of clinical trials are unknown, people who volunteer are considered “subjects” of the research being conducted rather than “patients.” They must understand that all the possible outcomes of the clinical trial may be much different from existing treatments. Before any individual is allowed to follow through in the participation of a clinical trial, they must have informed consent. According to the FDA, in order for the informed consent process to be effective, it “must provide sufficient opportunity for the participant to consider whether to participate,” which also involves allowing the individual enough time and opportunity to consider all the information and ask questions. You will sign a document at the end of the process stating that you are fully aware of what to expect going into the trial based on the information provided by the research team and any questions that they have asked beforehand.
This post was written by ClinicalTrialAdmin