Everyone involved in running studies should be trained and supported to manage participation changes for the good of both the participants and the study.
This should be done in line with applicable regulations and include an understanding of the importance of continuing study data collection wherever possible.
Training should acknowledge that satisfying participants’ wishes for less involvement in a study may not need to result in their participation stopping altogether.
Every member of staff involved in research studies should have clear training and guidance about managing participation changes.
We should recognise that helping participants do what is best for them, while also trying to do the best for the study, is a challenging task.
The nurses, doctors and other staff who run studies (particularly those who interact directly with study participants) should be given help and support in order to do this.
As well as reminding research staff about participants’ right to stop participating in the study at any point, without giving a reason and without negative consequences, the training should mention the importance of continuing study data collection (especially the data needed to answer the research questions of the study) until participants say they want it to stop.
It should also focus on understanding that if a participant wants to reduce their participation (for example only attend for routine clinic visits) this does not mean that they need to stop taking part in the study completely.
Relevant PeRSEVERE resources:
- See training and support for more specific guidance on this topic.
Relevant PeRSEVERE principles:
- Researchers should be aware, through their training, that researchers and participants losing contact with one another is not the same as participants saying they want to stop taking part in a study. See principles O4 and D4 for more on this.
- Researchers should be aware that study data collection should continue until a participant says they want it to stop. When a participant says they want to stop or reduce their participation in a study, the researchers should be trained and supported to make all reasonable efforts to find out whether or not the participant wants data collection to continue. See principle O5 for more on this.
- Training should make researchers aware of any ways for participants to continue contributing but with less commitment, so that they can discuss this with participants who are thinking about stopping participation. See principle D1 for more on this.
- Researchers should be trained and supported to have proactive discussions with participants about their participation. See principle D5 for more on this.
- Researchers should be trained and supported to collect complete and accurate data about how and why participation has changed. See principle M1 for more about this.
- We use the term “running” a study here to mean all activity involved in making a study happen, including getting the relevant approvals to start the study, working with the NHS and other organisations to set up study sites where participants will be recruited, making decisions about the management of the study, collecting and processing study data, and so on.
- Data collection: this means the act of adding relevant data onto study forms or systems, to make the data available for running and analysing each study. It does not refer to any separate tests or procedures used to generate the data in the first place.