To provide informed consent, trial participants must understand:
- The purpose of the trial
- What the trial involves (e.g. when the interviews occur, the importance of taking the medications strictly etc)
- The risks and benefits of the trial
- How their information will be used
- How confidentiality will be maintained
Participants must also have capacity to consent, and their consent must be completely voluntary. Participants can withdraw their consent at any time without any consequences whatsoever.
The Cadence BZ Participant Information Sheet and Informed Consent Form is 13 pages long, and there is a lot of information to take in.
To help potential participants and their families/carers fully understand the Cadence BZ trial, we have filmed a fictional dramatization (played by an actor) of the informed consent process for the trial.