Before participants agree to take part in a study, they should receive clear and balanced information about what will happen if they want to stop participating.
This should include information about how it is good for the study if participants can provide outcome data until the study ends.
This way, participants can make an informed choice about initial and ongoing involvement.
Before potential participants give consent to take part in a study, they should be informed about their right to stop participating and what this practically involves.
This information should communicate the advantages and the drawbacks of stopping or reducing their participation, both from their own point of view and from that of the study and its aims.
Potential participants should be made aware that their data is important and is needed to help decide whether a treatment works or not, even if they have to stop taking the treatment for any reason.
Having this balanced information helps participants make an informed choice about their initial and ongoing involvement in the study.
Potential participants should also get balanced information about giving a reason for changing their participation.
It is important that participants have the right to stop participating in a study without giving a reason, and that they are aware of this right. Researchers must not put any pressure on participants to explain decisions about changing their participation.
However, this does not mean that participants may not give a reason, if they are happy to. Knowing about reasons for participation changes can help researchers to reach more reliable conclusions when they analyse the study.
Participants should get balanced information on what their options are, including the advantages and drawbacks of different choices. They should use this to make their own informed, freely-given decision about what they want to do.
In many studies, it may be possible for participants to continue contributing but with reduced commitment, instead of stopping all aspects of participation.
The detailed information about exactly what choices participants have does not necessarily need to be given to participants before they agree to take part in a study.
Potential study participants are already given lots of information to consider at that point. Information about options for reducing participation might also not be relevant at that early stage, and might give the potential participant a confusing message about what taking part in the study would involve for them.
Instead, the details can be made available later on, at the time when participants are making a decision to stop, reduce or change their participation.
Pre-study information could, however, mention the possibility of participation reducing or changing as opposed to completely stopping, and encourage participants to speak to the researchers if they ever want to discuss this.
Information given at the start of the study should make it clear that any data collected before someone stops some or all study activities will be kept and used as allowed by data protection laws (such as the UK and EU General Data Protection Regulations).
Other important considerations
Under data protection laws, anyone using data about individuals needs a good reason to use the data. This reason is known as the ‘lawful basis’. In the UK, data in research studies is often used on the lawful basis that the research is being done in the public interest.
In other countries, data is sometimes used on the basis of individuals’ consent. This means the data is only used when participants have agreed to their data being used, and if the participants change their mind then the data cannot be used anymore.
In studies where data is used on the basis of consent, the information participants need to get before the start of a study will need to reflect this.
Relevant PeRSEVERE resources:
- Go to patient information, participant communication and consent for more guidance on this topic.
- See training and support for how to support research staff involved in informing patients or research participants.
Relevant PeRSEVERE principles:
- Participants should be informed, before agreeing to take part in a study, about the importance of collecting as much of the planned study data as possible. See principle O3 for more on this.
- Participants should be informed about what would happen to data collection and to data already collected, if they decided to stop taking part in the study early. See principles O5 and O6 about this topic.
- Participants should be told, before they agree to take part in a study, how they can find out about the study results when they are ready. They should be told that stopping participation early will not affect their right to stay in touch with the study, if they want to. See principle O7 for more on this.
- Participants should be informed about what would happen if contact between them and the researchers is lost. See principle D4 for more on this.
- Participants should be encouraged to talk to researchers as they progress through study about how they are getting on, and to highlight any challenges early. See principle D5 for more on this.
- Participants should be encouraged to tell researchers exactly what their wishes are if they later decide to stop or reduce their participation. They should also be informed about why it is helpful for them to explain their decision to change their participation, if they are happy to. These will help ensure there is good data about how and why their participation changed. See principle M1 for more on this.
- Outcome data: all research studies involve measuring something in order to reach conclusions. The thing being measured is the ‘outcome’, and data about it is the outcome data. For example, a healthcare study might give two groups of people different treatments, then measure how their health changes over time to see which treatment is better. The data about how the participants’ health changes over time is the outcome data. Outcome data is particularly important, because without it, studies cannot reach clear conclusions.
- 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.