This section covers information that participants should have already received. Although it overlaps with some of the topics already covered above, it could be useful to provide some specific reminders to help address common questions that participants may have.
Signpost to pre-study information sheet
In general, participants should be directed back to the information sheet they were given before the study, as this will contain lots of information relevant to the situation where they stop participating early.
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This includes what will happen to their data and any biological samples they have given in the study. These issues (and any others considered particularly important) could be specifically mentioned in the ‘signpost’.
Signposting should include clear details of who participants should contact if they have other questions about what stopping study participation will mean for them. Participants can also be directed towards any other relevant information elsewhere.
Example
You may want to look again at the information sheet you were given before you agreed to take part in this study, as it contains some important information about stopping your involvement. If you don’t have a copy of that anymore, speak to your study doctor or nurse to get another one.
They will also be able to help you if you have further questions about any of the points here, or if you would like to discuss what stopping your participation in the [study name] study means for you.
Reminder about what will happen to data already collected: “What will happen to the information you have collected about me?”
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In almost all research studies, data collected up to the point a participant withdraws consent will be retained and used in the planned analysis. It is a legal requirement to inform patients about this before they consent to take part in a study.
Participants may remember this at the time they decide to stop taking part, but if they do not, they should be directed back to the information they were given before the start of the study. Alongside the ‘signpost’, participants could be specifically reminded that their data will be retained, but also reassured that their data will be kept secure and confidential at all times.
Reminder about what will happen to biological samples already collected: “What will happen to the biological samples you have collected from me?”
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It is important to tell patients, before they consent to take part in a study, what would happen to any biological samples if they later decide to withdraw their consent for the samples to be stored and used for the research, and their options around this. Participants may remember this at the time they decide to stop taking part, but if they do not, they should be directed back to the information they were given before the start of the study.
It is also important to establish, when a participant expresses a wish to stop or reduce their participation in a study, whether or not they are still happy for their samples to be kept and used, both for the current study and for future research. Their decision about this should be confirmed to them as part of the summary of how their participation has changed (see “Summarising exactly how the participant’s participation has changed”, above).
It might be helpful to remind participants what biological samples they have given. This could be practically challenging to include in a written communication for all participants, but participants could be encouraged to contact their study doctor or nurse if they would like a reminder about this.
Possibility of finding out what treatment was received: “Can I find out what treatment I have been receiving?” (For ‘blinded’ studies where the participant and/or doctor do not know what treatment the participant is getting)
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In blinded studies, it is unlikely that participants stopping early will be able to find out what treatment they have been receiving until the end of the whole study, or at least until a certain amount of time after they joined the study. One exception is if the clinical team responsible for their subsequent care needs to know what treatment they have received in order to plan their subsequent treatment.
All of this should be made clear to participants before they agree to take part in the study in the first place, and so participants can be directed back to the pre-study information for a reminder, if they need it.
Availability of the overall study results: “When can I find out the results of the study? How can I find them out?”
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The pre-study information should give some information about how participants will be able to get the study results, if they want them. The ‘signpost’ could remind participants of the approximate timeline for this, and provide another copy of any links to where the results will be made publicly available (e.g. study registry page, study website).
Availability of individual test results: “Can I find out my own test results from the study?”
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In any studies involving medical tests or procedures, participants might be interested to find out about the results of those tests, if they have not had them already. This can include the result that the test was intended to look for, but also other, unexpected findings (including so-called ‘incidental’ findings).
Where this is relevant to a study because of the sorts of tests being carried out, the information participants were given before they agreed to take part should have made clear whether there might be any such individual test results to find out about, and how they could find out about them. This includes the potential to inform a participant’s family members about genetic test results, in cases where this is applicable. As this is a complex area, participants might be reminded of any specific measures for support or counselling that is offered alongside the notification of test results.
If the pre-study information did not cover this topic because it was not deemed necessary for the study, the information given at the time the participant stops taking part does not need to mention it either.
Complaints: ‘What if I have a complaint?’
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In some cases, participants may have stopped taking part in a study because something went wrong for them, and they are unhappy or upset about it. The pre-study information should always include information about how to complain about any aspect of their involvement in the study, and so this should be signposted in the information given to participants when they stop taking part. The availability of a way to complain should be presented neutrally and factually, without assuming there is or is not a problem to complain about, or to either encourage or discourage a complaint.
