Principle O7: information after stopping participation

Stopping participation early does not affect participants’ right to receive study-related information later on, if they want to receive it or if it could be important for them to have.

Participants may stop, reduce or change their participation in a study for a variety of reasons. The reason for participation changing may well have nothing to do with the participant losing interest in the study, or no longer supporting it.

It is therefore not right to assume that, just because a participant is no longer actively contributing to a study, they do not want to receive study-related information and communications, or that they may not be offered these.

When participants stop taking part early or significantly reduce their contribution, they should be asked about their preferences for further contact about the study, including receiving study results. This should be recorded as part of the data that is collected about the participation change.

Researchers should respect participants’ preferences, and also make sure that any later contact is appropriate to the participant’s circumstances (for example, taking into account things like the participants’ health having worsened in the meantime).

This principle also applies to participants who have lost contact with the researchers, although clearly in these cases it is not possible to find out participants’ preferences for further contact because contact has been lost.

Any further contact should therefore be in line with what participants were previously told about when they would be contacted, and with any contact preferences participants previously indicated.

Before researchers make contact with these participants, they should also make sure it is appropriate to do so (based on the information the researchers have about the participant’s circumstances), and that the participants’ contact details are still likely to be correct.

There may be various kinds of information that participants might be interested to receive.

This includes the final results and outcomes of the study, which should be offered to all participants in a research study, including those who stopped participating early.

The participant might also be interested to receive other, more general updates on the study, such as study newsletters, if participants are offered these.

There may be other sorts of information that are important for participants to find out about, particularly where it could impact on participants’ future treatment or care.

This could include new information about the study treatment they received (for example, information on side-effects that the participant could still experience).

It might also be important for participants to find out details of the treatment they received if they participated in a ‘blinded’ study where they were not told this at first (and at a time when researchers are happy that it will not affect the study integrity to share this information).

Finally, there may be information that is specifically relevant to participants who stop participating early because it is about their participation change. This can include clear information about what will happen next regarding their care, or about exactly which elements of their participation have stopped.

Participants stopping or reducing their participation in a study should get this information when they need it, to provide them with adequate support as their participation changes.

All information needs to be communicated to participants in a clear and careful way, and participants should be helped to understand the information and what it means for them.

Participating in research involves time and effort, and can involve some personal risk or inconvenience.

All study participants should therefore be thanked and shown appreciation for the contribution they have made to improving healthcare for patients like them in future. This also applies to participants who stop study participation early.

Other important considerations

Some studies go on for a long time. It is therefore possible that some participants may die or lose the ability to make their own decisions between the time when they stop participating in a study, and the time when information (such as information about the study results) is available later on.

Some other studies involve participants without capacity to consent from the outset (including studies where participants are children).

Decisions about whether or not the same information should be shared with the participant’s family members or carers in these cases are complex and depend on the specific details of each study and each situation. It is beyond the scope of our guidance to provide comprehensive guidance on this topic.

However, we recommend that researchers make a plan, with patient involvement, for how they will manage the provision of information in studies where a large proportion of participants are at high risk of dying or losing the ability to make their own decisions during the time the study is active, or where participants will not have capacity to consent from the outset.

The planning should include whether or not different sorts of information would be shared with relatives or carers, and a plan for whether or not this is raised with potential participants (or their relatives or carers) before they agree to take part in the study in the first place.

For other studies, it may still be sensible for researchers to have a planned approach, for example a way to decide the best thing to do for each specific participant given their circumstances.

Whether or not to share information with relatives or carers may depend on how much prior involvement those individuals have had in the study, amongst other things.

If it is not thought to be appropriate to contact relatives or carers directly, good public dissemination of information, such as the main study results, can still give those individuals the chance to find that information, if they want to.