Other information

The ‘other’ information mentioned here may be useful or interesting to participants, but does not necessarily need to be given so soon after the participant stops taking part (i.e. it can be given soon, but a delay is acceptable). We also suggest that the topics here are lower priority than those given in the sections above, so might not be prioritised for inclusion in a written communication where space is limited.

Giving feedback on the study experience: “Can I give any feedback about my experience taking part in this study?”

If there is some way for participants to give feedback on their experience taking part in the study, this can be made clear to them. Participants who have stopped taking part early might have particularly useful feedback. Research sponsors could use this to understand how to improve their studies and design them in ways that are easier or less burdensome for participants to take part in.

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General feedback is slightly different to the more specific information about a ‘reason for stopping’ (see below) – it has a different purpose and might be collected in a different way. In the case of this feedback, participants could be reassured that any feedback they give would be treated confidentially and would not be combined with any data collected about them for the study (or could not be combined, if it is collected anonymously). They might also be offered a chance to give feedback verbally or discuss their experience on the study with someone, if this is a possibility.

Although an invitation to provide feedback could be given very soon after a participant stops taking part, a delay is acceptable (or even desirable). At the later point the participant will have finished the process of ‘withdrawing’ from the study, hopefully resolved any initial queries about what will happen next for them, and perhaps will have had time to reflect on/cognitively process their participation in the study. Inviting feedback at the later stage also means it is uncoupled from the process of stopping participation, and therefore helps remove any sense that participants might be being asked to explain or justify any decision to stop taking part.

If there is no study-specific feedback mechanism, participants could be given details of more general feedback routes such as NIHR’s Participant in Research Experience Survey.

Reminding participants of the option to give a reason for their decisions: “Why might it be helpful to know why I wanted to stop taking part?”

Participants have the right to stop taking part in any study without giving a reason. However, if they are happy to give a reason this can help the study statisticians to better understand the study’s results. It is particularly helpful to understand whether participants’ reasons for stopping participation have anything to do with their health improving or worsening, because this can inform the overall research question in a study about which treatment is better.

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Participants must not be pressured into giving a reason for stopping. However, informing participants about why it can help the study if they do give a reason can allow participants to make an informed choice about whether to provide a reason. This can only be mentioned at the end of a participant’s time on a study if it was already mentioned in the information they were given before they agreed to take part.

From the participant’s point of view, there may not be much difference between ‘giving a reason’ as here versus ‘giving feedback’ as above. It is important they are separated from the researchers’ point of view because they serve different purposes. Information on reasons for stopping mainly informs study analysis, whereas more general feedback informs the design and management of future studies (or even the current study if feedback is received in time). This distinction could also be made in the communication for participants.

Example

If you would like to give any general feedback about your experience taking part in the study, we would very much like to hear from you. Please see [above].

You don’t have to give anyone a reason for stopping your involvement in this study. You may already have told your doctor or nurse why you wanted to stop taking part, or you may not want to do this. Either is completely fine.

However, as mentioned in the information you were given before you agreed to take part, it can be helpful for the study if you are happy to give a reason. This is because it can help the people analysing the study to understand the results of the study better. In particular, it is helpful to know if you stopping your involvement has anything to do with changes in your health. We would not need to know any more detail than that. It is completely up to you whether you want to share this information or not.

Feel free to contact your study doctor or nurse if you would like to tell them anything else about why you have decided to stop taking part in the study. Any information you give will be treated sensitively and confidentially.

Possibility of research involvement: “Can I get involved in any other research, or help improve how research is done in future?”

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It may be appropriate to give general information about other opportunities to participate in research, either through condition-specific resources, or more general resources such as NIHR’s ‘Be Part of Research’. It should in general be made clear to participants that stopping their participation in one study will not have any impact on their opportunities to take part in other studies (as long as they are eligible for those future studies).

Being a participant in a research study may also have increased people’s general interest in research. They might be interested to know about research involvement, where they can input into how other research is instigated, designed and run. They may also have a specific, useful experience to share as part of this, given that they have decided or had to stop taking part in the study early.

Participants can be provided with links to more information, such as condition-specific pages provided by Cancer Research UK or more general resources such as those provided by NIHR.

Current update on study status or other news about the study

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Some participants who stop taking part in a study early may still be interested to hear about how the study is going. This information is general and therefore should not take priority over the various individualised topics mentioned above.

Updates might include how study recruitment is going, or news of any significant milestones reached. If a study or the study treatment has been mentioned in the media, this could be mentioned and reflected upon.

Participants might also be reminded about ways to stay in touch with the study progress and find out the final study results, if they want to.

Frequently asked questions

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A list of frequently asked questions should only be included if there are any questions to mention. This can be a useful way for participants to quickly find answers to questions they have, including as alternative ways to get information that is already presented elsewhere. For example, although there may be a section in the communication called “How has my participation in the study changed?”, a participant might wonder, slightly differently, “Has my participation in the study completely ended?” A frequently asked questions section could help them find the answer to that specific question, mainly by referring to the other sections that cover this point. A similar approach could be taken on other topics, particularly about things participants are perhaps most likely to have questions about (such as plans for their subsequent care and treatment).