Patient info, participant communications and consent

Patient information sheets:

• Information sheets should be written with an understanding that participation changes can take many forms. Use language to convey this complexity.
• Participants must be made aware that they have the right to stop taking part in the study at any time, without having to give a reason and without effects on the standard of care they receive.
• They can also be made aware that it can help the quality of research studies if as much as possible of the planned data is collected.
• They can also be told why it can help the study when they give reasons for stopping their participation, if they are happy to do so (or want to).
• It should be made clear that the nature and extent of participation changes are primarily the participant’s choice.
• Potential participants should get information about generally what would happen if they decided to stop or reduce their participation later on.
• Where applicable, it should be clear that if a participant struggles to continue participating, it may be possible for them to continue participating but with less commitment.
• It may be useful to confirm that doctors will monitor participants’ safety and recommend they stop study intervention early, if it is no longer in participants’ best interests to continue receiving it.
• Potential participants should get clear information about what will happen if they lose contact with the study staff during the study.
• Mention any limitations on participants’ rights to stop or ‘undo’ aspects of participation.
• It should be made clear if data collection, or any other aspects of study participation, would continue until the participant clearly says they want it to stop.
• It should be clear that stopping or changing participation will not mean that participants cannot receive the results of the study or other information.
• Pre-study information should include anything else relevant to the process of stopping participation in the study, or the implications of stopping on things like incentives, or access to the study treatment(s), particularly where these could constitute negative consequences of a decision to stop participating.

Consent:

• Some aspects of managing participation changes might need to rely on consent from participants, for example where there are implications of participants’ confidentiality, or where planned study processes might otherwise be considered intrusive or burdensome.
• In some cases it may be necessary to seek others’ consent, for example if there are plans to collect details of a participant’s family or carer as part of managing participation changes.
• We suggest that sometimes it is not helpful or necessary to rely on consent for certain aspects of managing participation changes. Specifically, we recommend participants are not asked to consent to allow ‘presumed ongoing consent’ approaches (see above) or to be asked for reasons for participation changes.

Other participant communications:

• In the pages of this section, we provide further guidance on possible communications after initial consent, in particular to inform participants’ decisions about changing their participation, and to provide key information after participants stop or reduce their participation.
• We also outline some potential methods – not commonly used at the moment – that might support freely-given and informed decisions by participants about changing their participation. There are potential risks and benefits associated with each of these. Our suggestions are:
  • Participants could be offered an optional form to confirm how they would like their participation to change.
  • Participants could be given the chance to discuss their participation with someone independent of the usual study staff.
  • Participants could be offered a route to stopping their participation without having to speak to anyone.