Participants’ decisions about changing participation need to be mainly informed by information given before they initially consented to take part. This is important so that they can take the conditions of early stopping into account when they make that initial decision.
While participants can decide to stop only based on the prior information, there may be ways to remind them of their choices, such as via discussions with trial staff about participation (see principle D5 – encouraging dialogue).
Informed consent is often described as being a process rather than an event.
Arguably, participation changes should be viewed in the same way, beginning with a participant’s doubt about or difficulty with completing trial activities, and concluding with a participation change being carried out, along with any resulting, related actions.
Information could be important throughout this process. Alongside information being provided verbally to help the participant decide what to do, they could be reminded about the content in the original pre-trial information sheet, or given another copy if needed.
If any sort of form is used to collect information on participants’ wishes (see below) then this might also contain information to help guide choices, such as the implications, benefits and drawbacks of the different options.
Clearly, any such wording would need ethical approval before use. It could likely only repeat points made in the pre-trial information, rather than making them for the first time when participants are considering stopping taking part.