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).
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.
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.
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.