The nature and extent of participation changes should be the participant’s decision to make, within the limits of what is possible for a given study. Their decision should be informed and freely-given.
The only exception to this is where aspects of participation need to change or be stopped by someone else in order to protect a participant’s safety or well-being.
When people are considering whether or not to take part in a research study, their decision about this is theirs to make.
Their decision should be given freely, in that no one may put pressure on them to agree or to decline to take part. Their decision should also be informed by good information about what their choices are, and what the implications of these choices would be.
All of these things also apply when participation stops, reduces or changes.
Participants should get clear and useful information about what their choices are, to help them understand the various advantages and drawbacks of the different options.
Using this information, they should make their own decision (with the help or advice of others if they want) about how their participation will change. Their decision might be that they want to stop all aspects of their involvement in the study, but they might instead be happy to remain involved in some way.
Within each study, there will be limits to exactly how participation can change for a given participant.
Researchers should consider this when they are designing a study, and where it might be useful for participants to know, researchers should make clear to participants what changes to participation are possible, and therefore which are not.
In some studies where participation involves a number of aspects, participants may theoretically have many options about how their participation can change.
Researchers should consider how to avoid overloading participants with information and potential choices. This could involve organising the aspects of participation into ‘layers’ or ‘tiers’ to make participants’ choices easier.
It is also important that the fact of participants having options and being asked to consider them should not act as any sort of barrier to participants stopping all aspects of participation, if that is what they want to do. It should therefore still be straightforward for them to communicate this sort of decision to the researchers.
An important exception where someone other than the participant decides how participation will change is where someone else – usually a doctor or another person responsible for the participant’s care – will make a decision that it is in the participant’s best interests for some aspects of participation to stop.
This is often in the context of the participant stopping study treatment, if their doctor decides it is not safe for the participant to continue taking it.
Study protocols often have specific rules about when treatment should stop, if it is showing signs of not being safe or not at least potentially beneficial for the participant.
It is also possible that those responsible for the participant’s care, or the researchers, might decide that other aspects of participation should stop, if they feel that continuing them might not be in the participant’s best interests.
These decisions by others should only apply to relevant aspects of participation, and not beyond these. For example, if a doctor decides it is best for a participant to stop study treatment, then the treatment should stop, but other aspects of participation should stop only if the participant wants them to.
Whenever a decision like this is made on behalf of the participant, or where a participant is keen to continue participating but cannot do so in a reduced or alternative way within the particular study, the decision should be communicated and explained to the participant, clearly and in a timely manner.
The participant should also have the chance to ask questions of an appropriate person (for example, their doctor) so that they can understand why all or some aspects their participation has had to stop.
Other important considerations
Different considerations will apply in situations where individuals have lost capacity to give informed consent (or do not have capacity and have not since the study of the study). Applicable laws and guidance should be followed in these cases.
Related PeRSEVERE resources:
- See our guidance about Standard Operating Procedures and Writing research protocols for more on how good planning can help support participants to make decisions about their participation.
- For more on supporting participants’ decisions, see our guidance on informing potential participants, informing decisions about changing participation and other ways to support participants.
- For more on helping research staff who interact directly with research participants, see training and support.
- Our checklists for managing individual participation changes can guide the process of a participant stopping or reducing their involvement in a research study.
- See giving information to support participants who stop taking part.
Related PeRSEVERE principles:
- Information given to participants to guide their decision to change how they take part should include why, if they agreed to continue making a contribution to the study but with reduced commitment, this can be beneficial for the study results. See principle O3 for more on this.
- The situation where participants stop actively participating in a study without saying anything about what they want to do should be treated differently to a situation where they have expressed a wish to stop, reduce or change their participation. See principle O4.
- Study data collection is an example of an aspect of participation that can continue until a participant says they want it to stop, as long as all the conditions mentioned above are met. See principle O5.
- Participants should be made aware of the limits on their ability to have study data about them deleted, once it has been collected. See principle O6.
- Participants also have choices about what information they receive after they stop, reduce or change their participation. See principle O7.
- Researchers should decide when they are designing a study what choices will be available for reduced or altered participation, particularly focussing on allowing continued data provision with less participant commitment. See principle D1.
- Protocol instructions about managing participation changes should include how researchers can help participants make an informed and freely-given decision about changing their participation, as well as details of the extent of, and limits on, participants’ choices. See principle D2.
- Participants should get good information before they agree to take part in a study about what will happen if they later want to stop, reduce or change their participation, or if they stop actively participating without saying what they want to do. See principles D3 and D4 on these topics, respectively.
- Discussions between researchers and participants during the study and at the time of a participant deciding to change their participation can help the participant decide exactly what they want to do. See principle D5.
- Researchers should be adequately trained and supported to help participants make an informed and freely-given decision about changing their participation. See principle D6.
- Study protocol: this is the document (or set of documents) that describes why a study is needed, what it aims to achieve and how it should be run.
- Capacity or capacity to consent means a person’s ability to make decisions for themselves. In the context of research, it means a person’s ability to give informed consent to take part in a study. Some people have a varying or reduced ability to make decisions for themselves, for example people with dementia. By law, children also do not have capacity to consent, so their parents or guardian need to consent (or not) on their behalf.