What is the Persevere project about?
The PeRSEVERE principles aim to guide everyone involved in research about how to prepare for and manage “participation changes” – this means when research participants stop, reduce, change or increase their involvement in a study, whatever the circumstances.
Participation changes can be complex, and our principles aim to give everyone clarity and confidence about the right approach.
What might be a research recruiter’s role in helping to manage participation changes in research studies?
Recruiters in research studies are those who recruit participants and then are in direct contact with them during the study.
They introduce a study to potential participants, setting out what a study would involve and what the potential benefits and risks of participation might be. This includes explaining what people’s rights are if they decide to take part – including the right to stop taking part at any time, without having to give a reason and without their standard care being affected.
Recruiters can help potential participants understand what to expect if they stop or reduce their involvement in a study, especially if they have questions or concerns about this.
For those who decide to take part, recruiters can help identify issues participants might be having with their involvement in a study, and suggest ways to help.
They can support participants who want to stop taking part. This includes helping participants understand their choices about how their involvement could change, and helping participants decide what to do.
Finally, recruiters are usually responsible for making sure a clear record is kept about how each participant’s involvement has changed, and what further involvement the participant might have in a study.
Which PeRSEVERE principles might be most relevant?
The principles are coded with O for ‘overarching’ principles, D for study design and setup issues, M for data management and monitoring, and R for study analysis and reporting. See the main PeRSEVERE principles page for more details.
- The principle O1 explains how participation changes can be complex, rather than a simple matter of participants still taking part or having ‘withdrawn’. Often, there might be various ways that participants might change their involvement in a study. This is a key idea in the PeRSEVERE project, and it’s important that everyone understands it, including recruiters and those they work with.
- Principle O2 says that the extent and nature of participation changes are mainly each participant’s choice. This means if a participant indicates that they want to stop taking part, it is important to help them work out exactly how they want their participation to change. This can be challenging in practice, and we provide guidance to help.
- Principle O3 says that everyone involved in research studies should be aware that it helps the study to collect as much as possible of the planned data. This includes recruiters and participants. It doesn’t mean that this consideration takes precedence over others, just that it shouldn’t be forgotten. When a participant is finding it difficult to continue with all aspects of a study, they might be interested to continue taking part with less commitment. It’s important to consider what adjustments could be made to accommodate them.
- Principle O4 confirms that participants and research staff losing contact with each other is not the same as participants saying they want to stop taking part. Contact might have been lost because the participant wants to stop, but it might have been lost for a different reason. Studies should have a plan for this situation, including whether further data might be collected or further attempts might be made to re-engage with the participant.
- Principle O5 says that data collection should continue until a participant says they want it to stop. This is an important way we can protect study quality. The approach is not unconditional, though, and we explain how it can be done fairly and transparently.
- Principle O7 says that stopping participation does not mean that participants shouldn’t be able to receive information about the study later on, if they might want or need it.
- Principles D3 and D4 are about how to create clear and balanced information for potential research participants about changing their participation.
- Principle D5 is about participants and recruiters being able to discuss the participant’s involvement as needed. This includes the recruiter checking the participant’s willingness to continue taking part at suitably regular intervals, and participants being encouraged to mention any issues they are having in case they might be resolvable.
- Principle D6 says that everyone involved in managing participation changes in research studies should have the training and support they need. Managing participation changes can be challenging – perhaps especially for those in direct contact with participants.
- Principle M1 is about recording good quality data about participation changes, so that everyone is clear about how each participant’s involvement has changed, when it changed and – if known – why.
Which PeRSEVERE resources might be most useful?
- Our guidance on:
- Checklists for those interacting with participants to remember the various things they might need to do when different sorts of participation change occur.
- Guidance on what sorts of information participants might need when they stop taking part in a study.
- Scenarios explaining how the Persevere principles can help.
- Suggested terminology for talking about participation changes (in any context).
- Template patient information sheet wording.