In putting together this guidance, we have considered information that participants might want or need to know about when they stop taking part in a study early, as well as information that researchers might want or need to tell participants about. There is therefore a wide range of possible things to communicate to participants.
In this guidance, we have suggested that information can be grouped into the following areas (covered in more detail in the sections that follow this one, with examples where helpful).
Important new information about changing involvement in the study, and important new information about post-study arrangements and the transition to these
This is information that is particularly relevant to the participant’s current situation, i.e. because they have recently stopped taking part in some or all of the study. It is ‘new’ in that it might not have been provided before (because it was not relevant or applicable before) or might be expanding on information previously given, now that the participant has reached this point.
This information should be provided soon after it is confirmed that the participant is stopping taking part in the study. It should be given at this time because it is not appropriate to delay it. It may not be necessary (or practical) to give all this information on the same day as the participant stops taking part in a study, but it should not be delayed for long after this.
It should include information that the participant may need to know at that time, or information they are very likely to want to know.
Important reminders and signposting
Some other information may be just as important to participants, but either was provided already (particularly as part of the pre-study information) or is available elsewhere. Signposting to this information, rather than repeating it, means we can reduce the length of a communication given to participants after they stop taking part. This approach also allows participants to seek out and find the information they want to find, rather than having to receive all of it by default.
These reminders and signposts address questions that might be important to a given participant, so they should also be provided soon after the participant stops taking part.
Some other types of information might be useful to some participants, but are perhaps less likely to be important to everyone.
These can be provided immediately after the participant stops taking part, but a delay is possible if it is more practical to do so for a given study, or to avoid making the initial communication too long. It should nonetheless be provided to participants within a timeframe that is reasonable in the context of the study.
We acknowledge there may well be some overlap between some of the topics covered in these areas. However, we might assume many participants may not read all of the information front-to-back, but instead use it to understand the key points and find information they are particularly interested in. On this basis, a small amount of duplication means participants are more likely to find answers to their questions (because there is more than one ‘route’ to the answers).
Organising the information
The best ways to organise the information will depend on the study, and involved patients can advise about what works for the study and its participants.
We suggest the initial communication given to participants is no longer than 2 sides of A4 paper (in at least 12-point font) or equivalent for email and online formats. If there is more information to convey, this can be provided in an accompanying leaflet or webpages with an invitation to read on if the participant is interested.
If information will be provided in layers (e.g. a summary then more detail about the same points), we suggest that the shorter and the more detailed layers present information in a similar order to help participants navigate through the material. Contents pages can also be used to help participants find their way through any longer layers.
Links between different layers of information should be meaningful, rather than just basic signposts. So rather than just “You can read about what will happen to your information in [the longer information]”, consider “As we mentioned before you agreed to take part in the study, the information we have collected about you so far will still be used in the study analysis. You can read more about this in [the longer information].”
Who should the information come from?
It may be appropriate and practical for important new information and signposting to come from the participant’s primary contact for the study, for example the doctor or nurse they usually see, rather than from a research sponsor who may not usually be in contact with them.
Good study-specific templates and guidance will be important in allowing standardised information to be delivered to participants in a timely manner. It is also important for research sponsors to engage with research sites to agree how the information can feasibly be delivered to participants in a timely manner.
The ‘other information’ could come from the research sponsor or their representative, or the study Chief Investigator, if that is appropriate within the specific study setting. If a second contact is planned (e.g. an initial communication showing the important information then another more general communication later on), the second contact and its contents could be mentioned in the first one, so that participants know to expect it. The second communication could reiterate some of the key points from the first one, if that might be useful.
Reminding participants of the pre-study information
A lot of relevant information about stopping participation will have been contained in the information each participant was given before they agreed to take part in the study. It might be appropriate to give participants another copy of this (or the last version that they gave consent to, if they updated their written consent during the study) when they stop taking part. However, this might not be necessary if it has not been long since they gave their original consent.
In that case, participants might be advised to ask for another copy if they need one. Each study should work out its own approach that finds a balance between providing access to information without barriers (such as needing to ask) and not overburdening participants with information they are likely to already have access to.
Pre-study information sheets can also be made available online. If this is done it must be clear to each participant which version of the information sheet is relevant to them, if several versions are available. The same information must also be available in hard copy for those who need or want it.