Patients and public contributors

Public contributors are essential members of study teams.

They are often asked to review patient-facing documents before they are used in research studies. In reviewing these documents, they can see what researchers plan to tell potential study participants about what will happen if they stop or reduce their involvement in the study.

Sometimes public contributors are asked to review study protocols. These should include plans for what members of the research team will do when participants say they want to stop taking part in the study, or if participants and researchers lose contact with each other. Public contributors might review these plans to check they are appropriate.

Some public contributors are members of committees that oversee ongoing studies. In this role, they might be involved in reviewing summarised information about participation changes in studies, and helping decide whether any action is needed.

• Have researchers designed the study to be as burden-free as possible for participants?
• Have researchers planned ways for participants to stay involved while making less commitment, as opposed to only being able to continue all participation or stop it all?
• Is it clear from patient-facing documents and the study protocol that participants might be able to stop some aspects of the study while carrying on with others?
• Will it be clear to participants what their choices are about stopping or reducing their participation and how they can communicate what they want to do?
• Does information for patients/participants encourage them to speak with their doctor/nurse if they are having problems participating, in case their difficulties could be resolved in a way that allows them to continue contributing if they want?
• Have researchers considered how to present the choices available and avoid the possible complexity of choices?
• Are potential participants given complete and balanced information to inform their choices?
• Do the researchers have a plan for what to do if research staff cannot get in contact with a participant? Will the plan seem reasonable and fair from participants’ point of view?
• Do the researchers plan to continue with some aspects of participation until a participant specifically says they want them to stop? If so, are they doing this fairly and transparently?
• Do researchers’ plans for sharing study results with its participants include how to share results with participants who stopped early but still want to find out?
• Do researchers have plans to check participants’ contact preferences and details when they stop taking part?

The principles are coded with O for ‘overarching’ principles, D for study design and setup issues, M for data management and monitoring, and R for study analysis and reporting. See the main PeRSEVERE principles page for more details.

• The principle O1 explains how participation changes can be complex, rather than a simple matter of participants still taking part or having ‘withdrawn’. Often, there might be various ways that participants might change their involvement in a study. This is a key idea in the PeRSEVERE project, and it’s important that everyone understands it, including public contributors and those they work with.
• Principle O2 says that the nature and extent of participation changes should be mainly based on participants’ choices. This means that if a participant is finding it difficult to complete all parts of a study but could still contribute with less commitment, they should be offered this choice. Researchers need to think about how to avoid making the available options too complex for participants. In the cases where aspects of participation need to stop because of some other reason than the participant’s choice, researchers need to think about how to communicate this clearly.
• Principle O3 encourages everyone involved in research studies – including participants – to bear in mind that collecting more of the planned data supports study quality. This in turn is good for future patients and the other participants in the study. It does not mean this consideration takes precedence above all others, but that it is not forgotten. This needs to be communicated carefully to potential participants before they agree to take part in a study.
• Principle O4 says that when researchers and participants lose contact with one another, this is not the same as participants saying they want to stop. It might sometimes mean they want to stop, but not always, and there may not be any way of knowing (because contact has been lost). Researchers should make a plan, with public contributors’ input, for what they will do in this situation.
• Principle O5 says that data collection in research studies should carry on until participants say they want it to stop. This is important to support study quality, but it needs to be done carefully. Researchers should follow our guidance to make sure they are doing this fairly and transparently. They should remind participants of any ongoing data collection at suitable times.
• Principle O6 confirms the well-established idea that data already collected before a participant says they want no more data collection should be kept and used in the study analysis. This supports study quality, and therefore benefits patients in future who could be impacted by the study results. It should be made clear to potential participants before they agree to take part.
• Principle O7 says that stopping their participation shouldn’t mean participants can’t get information they might want or need. This includes the overall results of the study, but also things like newsletters or information about what treatment they received in a ‘blinded’ study (at the time when it is appropriate for them to have this information).
• Principle D1 encourages researchers to think about how participants could continue taking part with less commitment, if they are still keen to contribute.
• Principles D3 and D4 are about making sure information for potential participants explains clearly what will happen if participants stop taking part, or lose contact with the research team.
• Principle D5 says participants and researchers should be able to discuss the participant’s involvement whenever needed. This means the researcher should check that the participant is happy to continue taking part reasonably often (but not too often). Researchers should also encourage participants to raise any issues with their participation, in case something can be done to help.
• Principle M1 says that researchers should collect good quality information about how participants are changing or reducing their involvement in a study. Sometimes this might mean asking participants to provide information directly, for example by completing an optional form.
• Principle M2 says that researchers should regularly check information about participation changes in their study. Public contributors may help with this checking and deciding what to do in response to any findings.
• Principles R1 and R2 are about doing study analysis and reporting study results to take account of how participants have changed their involvement. Public contributors may sometimes be involved in these activities.

• Our guidance on:
  • Protocol development
  • Patient information, participant communications and consent
  • Data collection about participation changes

• Checklists for those interacting with participants to help them remember the things they might need to do when different sorts of participation change occur.
• Guidance on what sorts of information participants might need when they stop taking part in a study.
• Scenarios explaining how the Persevere principles can help.
• Suggested terminology for talking about participation changes (in any context).
• Template patient information sheet wording.