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 M Participant Information Sheet and Informed Consent Form is 13 pages long, and there is a lot of information to take in.
A video dramatization of the consent process for another Cadence study (Cadence BZ) is available here, to help you understand the general consent process.