- Information to Support Participants Who Stop Taking Part: Guidance for Researchers
- Suggested process for developing communication strategy and materials
This section covers a suggested process for developing a communication strategy and materials for giving information to study participants who stop participating early. We strongly recommend that the details of this approach are considered during the setup of a study, rather than trying to introduce a new participant communication approach part-way through, and our guidance is written from that point of view.
- What features of the study and its design or setting might be relevant to consider? For example, is it a ‘double-blind’ study, and, if so, how might this affect the planned communication?
- How many participants do you predict will stop taking part early? Is there a risk that a relatively large number of participants will do this?
- Do you expect most participants who want to stop taking part early to tell the researchers this, or do you suspect some will indicate their wishes by no longer replying to researcher contact?
- Might participants stop taking part because their health is deteriorating?
- Are participants at relatively high risk of losing the ability to make their own decisions during the study (also known as losing ‘capacity to consent’)?
- Who are participants mostly in contact with during the study – a healthcare professional such as their doctor or nurse, or research staff in a university or other institution, or both, or someone else? How might they interact with this contact if they stop participating?
- Who are participants most likely to feel comfortable talking to about aspects of their study participation? Might this change if participants stop taking part?
- What other factors might be important in how you will communicate with participants (such as issues of culture, language or disability)?
You might also consider the expected ‘pathways’ of participants who stop taking part in the study. Who might they interact with, and when? Who will be informed about the change in their involvement in the study, how and when? An example pathway is given on the Appendix page.
Based on the possible pathways, consider how the information will be delivered in a way that is convenient and minimises the burden for participants as well as research staff. Will the information be given as a paper document (often still preferred) or might it be appropriate to give participants a link to a website (with a paper copy on request)? Might email be the best method?
Involve patients in deciding the best approach to accessibility, as well as advice from any other local or national organisations relevant to the study and its participants.
There are various resources available about ensuring information is accessible; a non-exhaustive list is given in Further Information.
The contents of pre-study information sheets are out of the scope of this current guidance. However, we have included some suggestions below.
If some of these points are not included in the pre-study information, it can be inappropriate (or even unethical) to mention them only later when a participant stops taking part.
Possible information about ending participation to add to pre-study information:
- Where applicable to the study, it should be clear that if a participant is finding it hard to continue participating in the study, it might be possible for them to continue participating but with less commitment. They can be advised to speak with their study doctor or nurse if they are finding participation difficult but are interested to know if a reduced ‘level’ of participation might be possible.
- Participants must always be made aware that they have the right to stop taking part in the study at any time, without giving a reason and without affecting the standard of the 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 be helpful to the study for them to give reasons for stopping, if they are happy to do so (or want to). These points must be made sensitively, using wording approved by an independent research ethics committee. Informing participants of these points gives participants ‘balanced’ information and allows them to make informed choices about stopping or changing their participation. It is unethical for pressure to be put on participants to continue participating in a study, or to provide a reason for stopping. However, we suggest it is also not appropriate to deny participants information about their choices, and information to guide those choices, if they may be keen to continue supporting the study as much as they can. In any case, participants should be reassured that whatever they decide is OK, and there are no ‘wrong’ decisions.
- Depending on the nature of the study and the treatments involved, it may be useful to confirm that doctors will keep an eye on participants’ safety and recommend they stop study treatment(s) early, if it is no longer in participants’ best interests to continue receiving it/them. This may not be useful if it could cause participants unnecessary concern or worry, but may be important if a study treatment is new and its safety is not well understood. If content about this is included, care must nonetheless be taken to do it in a balanced and sensitive way, to avoid causing unnecessary alarm or concern.
- Participants can get clear information about what will happen if they lose contact with the researchers during the study. For example, this might include any approaches the researchers might take to get back in touch with participants, or any plans for researchers to contact other healthcare professionals (such as GPs, with participants’ consent) to find out if they have any information on how participants are doing.
- Any limitations on participants’ rights to stop or ‘undo’ aspects of participation need to be mentioned up front. This includes any limitations on rights to have data about them deleted if it was collected before they decided to stop participating. It also includes limitations to have any biological samples destroyed if they have already been used. In some cases it may not be possible to stop some sorts of data collection, such as collection of data about side-effects in some clinical trials of new drugs where this data collection is a statutory requirement.
- Researchers may want to make clear that data collection about a participant would continue until the participant says they want it to stop. This means that if a participant says they want to stop taking a study treatment (for example) but does not say (even after having been asked) that they want to have no more data about them collected, collection of data relevant to the study would continue. If this approach is taken, it must be clear to participants how they can express a wish for data collection to stop if that is what they want. Research staff must also make reasonable efforts to find out the participant’s wishes (usually through discussion with the participant at the time they are stopping or reducing their participation in the study). This approach should be applied conservatively. For example, if a participant has not specifically said they wanted data collection to stop but there are reasons why further data collection seems inappropriate (perhaps based on something the participant has said, or based on known changes to their personal circumstances), then it should stop. In our guidance below, we suggest that if researchers intend to continue collecting data about a participant after they stop participating in some elements of a study, they should make this clear at the time the participant stops taking part. This should help ensure the approach is transparent, and ensure that participants definitely do have a choice in the matter.
- 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)
This includes the pre-study information (see above), but consider as well how this proposed communication fits alongside others used in the study. This might include newsletters for participants, messages of thanks given to all participants at the end of the study, and messages communicating the results of the study.
Where there will also be a general ‘end of study’ information sheet for participants, ensure it will be clear when to give participants that and when to give the information about ending participation early (for example, which one would you give to a participant who stops taking part before the end of the study, but very close to the end of the study?)
Draft the template using this guidance, as well as any other relevant guidance for producing participant communications. Use plain, accessible language and consider graphics and diagrams where these might help convey important information.
The communication’s length is also important. The primary written communication for participants should ideally not be longer than 2 sides of well-spaced A4 paper (or an equivalent length for emails or online materials). If there is more information to make available than this, then these 2 sides should be used to summarise the key points from the longer content and guide individual participants towards the information they might be most interested in.
Ensure the communication contains basic elements such as a date, a clear trusted source (i.e. decide who the communication should come from and who ‘we’ is if that is the pronoun used), the study name and identifiers, and links to the study website and public registry page.
The communication should also have a clear, engaging title. An example title might be: “[Study name]: what happens now that your involvement has ended?”
The first sentence(s) of the communication (possibly after an initial ‘thank you’ message) should make clear what it is for, why it has been given to the participant and what they are expected to do with the information (if anything). For example:
You do not have to do anything in response to this message. It is yours to keep, so please read as much of it as you want to, to help with any questions you may have. But there may be things mentioned here that you might want to talk to your study doctor or nurse about. You will find a reminder of their contact details [below].”
Communications should include (e.g. at the end) a general invitation to contact an appropriate person (with that person’s contact details) if the participant has further questions or would like to discuss anything.
At the time of developing this guidance, it is likely uncommon to provide any sort of communication to participants who stop taking part in a study early. It is therefore possible that a given research ethics committee may not have been asked to review this sort of thing before, and may not see why it is necessary.
In the accompanying cover letter (or equivalent) to the ethics committee, consider making clear that this sort of communication is about ensuring participants get the information they need and want, at the right time. You could also explain that part of the process around providing the information will help ensure that individuals’ needs are considered, and no participants will be given information where it is not agreed to be appropriate to give it to them. It may also be important to highlight that the information is in no way aiming to encourage participants to reconsider a decision to stop taking part in some or all of the study. Finally, consider mentioning that you followed this guidance, which was developed by patients working with researchers, to develop the patient-facing materials.
Where relevant in this guidance, we have explained why we think some topics should be included in a communication for participants. These may be useful in explaining the approach to ethics committees to inform their review.
If the participant’s clinical/care team advises that it is not appropriate to contact the participant at this time, those running the research (e.g. research sponsors or their representatives) must respect this. Care may also be needed if some time has passed since a participant had stopped taking part, to make sure planned communication is still relevant, useful and appropriate to be given at this later time.