According to the PeRSEVERE principles, the nature and extent of participation changes should primarily be driven by informed, freely-given decisions by participants (see principle O2).
We acknowledge that achieving this may be a challenge.
For example, it could be challenging to ensure participants make a truly ‘informed’ decision while not making this information step any sort of barrier to stopping participation.
Given participation in trials can be multi-faceted (see principle O1 – participation can stop, reduce or change), there is a risk of participants being overwhelmed by choices (though the use of ‘tiers’ of participation could help with this – see Protocol Development).
It may benefit the ‘informedness’ of decisions for participants to discuss what they want to do with someone (see principle D5 – encouraging dialogue), but their main trial contacts may have a real or perceived conflict of interest (in that they work on the trial) which could affect how ‘freely-given’ the participant’s decision can be.
Below, we propose some mechanisms that may support participants to make informed and freely-given decisions about how they want their trial participation to change.
Some of these may already be done to some extent. We acknowledge challenges or risks inherent in some of these proposals, so they should be adopted only if the likely benefits outweigh those risks.
Further work to assess the feasibility of these proposals and exactly how to put them into practice would be welcome.
Participants could be offered an optional form to confirm how they would like their participation to change.
This would always need to be optional, and it would need to be clear for participants that they could stop their participation without completing the form.
The benefits of completing the form could be conveyed on the form, i.e. it helps make clear to the trial staff exactly what the participant wants to do.
The form could reduce the complexity of choices by offering the participant ‘tiers’ of participation (see Protocol Development). Information on the form would explain what each ‘tier’ involves and whether there is further flexibility (i.e. other options not mentioned in the tiering).
The form could give participants an opportunity to explain the motivation(s) or other factors influencing their participation change, if they are happy to do so. They could be reminded of why this can be useful to those running the trial.
Specific questions or standardised lists of possible reasons (rather than open questions) could help reassure participants that only a certain amount of detail is needed (see Data Collection About Participation Changes).
The form could include questions about participants’ preferences for further contact about the trial, for example to find out if they would still like to receive trial updates and the overall results of the trial when they are ready.
The form could be in a standalone paper or electronic format or could be part of an eConsent system. (Other examples of participants managing their ongoing consent more closely via ‘dynamic consent’ systems have been reported in the scientific literature previously [e.g. in reports by Kaye, Williams and colleagues).
Participants could be given the chance to discuss their participation with someone independent of the usual trial staff.
This could help remove the impression of conflict of interest when the participant discusses their participation with trial staff. (Trial staff have themselves reported difficulties managing their ‘dual roles’ in giving clinical care and running the trial.)
The expectation would be that the ‘independent’ person would be able to give balanced advice, understanding the pros and cons of different options from the point of view of the participant and the trial.
The independent person may need specific training to fulfil this role.It could be someone with clinical expertise or not. It could be someone affiliated with the trial (e.g. the ‘concierge’ role used in some pharmaceutical-sponsored trials) or affiliated with a trial site, or a representative of a relevant charity or support organisation.
Participants could be offered a route to stopping their participation without having to speak to anyone.
This might primarily need to be online, but it could conceivably be done by post or automated phone line. It could alternatively be a built-in part of an eConsent system.
Some evidence suggests that some participants feel awkward about saying they want to stop taking part, or feel they might be letting the trial staff down.
This may be the reason for some cases where contact is lost between trial staff and participants, i.e. the participant wants to stop taking part but does not want to talk to anyone about it.
A ‘risk’ with this approach is that participants may not be making an informed decision (as PeRSEVERE principle O2 says they should), i.e. they may not have understood the implications of their decision for them or the trial. If may be possible to implement the approach in ways that do help inform the participant about the main implications.
It would not be ideal if participants mistakenly thought this was the main way to communicate that they wanted to stop participating (as opposed to choosing this route only because they did not want to talk to the trial staff about their participation).
It is therefore important to consider whether the benefits outweigh these risks, and to implement this approach with care.
Emphasis should still be placed on having a conversation with the trial staff as the preferred option where that was acceptable to the participant (see principle D5 – encouraging dialogue). The benefits of the discussion to the participant could be made clear, particularly the possibility to keep contributing in some different way.
The option to stop or reduce participation without speaking to anyone should be considered alongside the participation ‘tiering’ (see Protocol Development), i.e. regarding which participation tier the participant moves to following a notification via this route.
A potential benefit of the approach might be to reduce the number of participants recorded as having lost contact with the trial, by giving participants a way to confirm their wishes without having to speak to someone, at least providing some clarity for the trial team in the process.