Important new information about post-study arrangements

Immediate arrangements after the study: “What needs to happen now that I have stopped taking part?”

It should be clear to participants if there are any specific actions required from them after ending their involvement in the study, with reasons for these if they might not be obvious.

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The exact points to include will depend on the study, but may include: how to safely stop taking study treatments; information or reminders about any final study appointments that may be requested or encouraged (for example to help assess participants’ health); information about returning leftover study treatment or equipment, or a reminder about picking up belongings if the study involved a stay away from home.

This information may be conveyed verbally or in more general written communications between the doctor and the participant. The most important points may also have been covered in pre-study information sheets. However, the written communication at the time of stopping participation should mention any key points and/or encourage the participant to speak to their doctor or nurse if they have any queries about what is expected of them. The participant might also be provided with a checklist of things to they might want to ask about.

Arrangements for post-study care: “What will happen to my care now? Can I still access the study treatment? Might there be more side-effects in future?”

Participants may very reasonably have questions about their future care now that they have stopped taking part in the study.

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We expect the specific details of post-study care to be conveyed verbally and in general written communications between the clinical/care team and the participant. The study-specific communication might help the participant with the sorts of questions to ask and who to talk to if they do not yet feel they have had enough information. As mentioned above, this could include a checklist of things that they might want to ask about.

The clinical/care team would be best placed, for example, to give the participant details about the treatment they have had during their time on the study, the plan for their treatment after the study, whether the study treatments are or will be available outside the study, and any important information to know before trying other treatments.

Some points that could be included in the study-specific communication:

  • Reassurance/reminder that the participant stopping taking part in the study early will not affect the standard of care that they will receive.
  • Reassurance/reminder that stopping taking part early in this study will not in itself restrict their opportunities to take part in research studies in future, as long as they are eligible for those future studies.
  • Whether or not any other healthcare professionals (especially their GP) will be notified about their stopping participation in the study.
  • A reminder about any longer-term risks or potential side-effects that could occur in relation to the study treatment, how to manage these and who to tell about them.
  • The possibility of updated information becoming available about the safety of the study treatment and how this would be communicated (though this might fit better in text above on future communication about the study).

Some relevant information may have been given in the pre-study written information, for example about whether the study treatment is available outside the context of the study. If so, this information can be signposted, and participants given the opportunity to have another copy of that pre-study information if they need it.

Available support: “What support is available while I end my participation in the study?”

It is important to make clear to participants throughout their time on a study (not just when they end their participation) what support is available. This may be general support such as the local Patient Advice and Liaison Service or more specific support related to the participant’s health condition or their participation in the research.

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It is not likely to be helpful to say that there is no particular support available even if this is the case, but if there are specific mechanisms in place then these can be mentioned by the clinical/care team, and the study-specific written communication can encourage participants to ask their clinical/care team if they need more support.

Even just having the opportunity to discuss their involvement in the study with someone in confidence might be valued by a participant. This might not need to be the same individuals they talked to during their time on the study, and it might even be helpful in some cases if it is someone different.