Introduction

What is this document and who is it for?

This document gives guidance for researchers to provide information to research participants who stop their participation early (including those who ‘withdraw’ from a research study) while the study continues. It is primarily for use in healthcare research involving individually consenting participants who contribute over a period (rather than where participants only make a one-off contribution). Where we say ‘researchers’, this includes anyone running or overseeing a research study who might want or need to provide information to research participants stopping their participation early.

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It can apply to a range of situations where participants stop taking part in some or all of a research study before their participation was originally due to end. This includes both where this was their decision and where it was someone else’s. It also includes where participants do not tell researchers that they want to stop taking part, but instead stop taking part by no longer responding to researchers’ attempts to contact them.

Although the guidance can be used across a range of situations, we suggest it is most relevant where it will be obvious from the participant’s point of view that their participation in a study has stopped or substantially reduced. It may be less useful where their level of participation has changed but they still feel they are ‘in’ the study (for example, if they stop a study treatment but will continue with all other elements of participation).

The guidance is not intended to cover the situation where a participant stops taking part in a study due to loss of capacity to consent (i.e. where any communication might be with the participant’s family/carer, if appropriate). However, many of the points raised may also be relevant in that situation, and might give the family/carer clarity about the implications of the participant’s involvement in the study ending. Clearly, cases like these would need to be handled sensitively, particularly if the family/carer were not aware of the participant’s involvement in the study, or were not happy about it (for example). You may find the ‘Capacity and Consent to Research Resources’ website useful for more on capacity to consent.

Our guidance is not intended to be relevant to communication with a participant’s family/carer when the participant has died during their time taking part. Many of our recommendations would not (and could not) apply in that situation. We suggest researchers consider this issue separately, especially for studies where a large proportion of the participants may be at risk of dying before the end of the study.

Although some information can and should be provided to participants verbally, the focus of this guidance is on providing information in writing. As with other types of information for participants, giving information in writing has several advantages. This includes that the participant can read and digest the information in their own time (which may be particularly important for some, for example neurodiverse people) and that they have a copy of the information to keep. It also allows review of proposed wording by an independent ethics committee prior to use. We nonetheless suggest that participants should also be given the opportunity to receive information verbally where they would like this, and get the chance to discuss the information (and ask any questions they may have).

Why should research participants who stop taking part get good information?

In general, it is right that participants in research projects are kept up to date with what is happening during their time taking part. People who stop taking part in research studies early likely also have particular information needs.

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Participants often give considerable time and energy to their participation. Their participation may be very important to them, especially if they are taking part to receive a new treatment that may improve the quality or length of their life. It could therefore be seen as a basic courtesy for researchers to provide participants with information during the study, whenever they want or need it. Absent or inadequate information, on the other hand, may affect participants’ trust and confidence in a study, and their willingness to take part in research in future. A recent report of the NIHR’s annual Patient Research Experience Survey recommended that participants should get “the right information…in the right place at the right time as [they] proceed through the study.”

People who stop taking part in research studies early also have particular information needs. Although they will get some information at the start of the study about what would happen if they stopped taking part early, this may not prepare them fully for when it actually happens. Ending participation can be a stressful experience and participants can sometimes feel unsupported or even ‘abandoned’.

While there is existing guidance about providing information to participants at the end of a study (for example from the Health Research Authority) there is limited guidance specifically about providing information to participants when they stop their participation early.
We suggest at least the following key areas of information that could be important to this group of participants:

  • Clarity about exactly how their participation has changed: which aspects of participation have ended and which have not, and the choices now available to them.
  • Communication of gratitude and appreciation for their participation; some participants may have concerns that ending their participation early means they have not made an important contribution, so it is important to make clear that they have, and to thank them for it.
  • A reminder of what stopping early means for them, and for any information and biological samples they have given; these topics will have been covered in the information they received before they consented to the study, but a reminder could be useful for some.
  • Information about what happens next from their point of view, particularly regarding their care.
  • Any other information that individuals might want or need: this includes how to get the results of the study, when they are available.

Can research participants be contacted after they withdraw from a study?

We accept that there can be sensitivities around researcher contact with participants after they have stopped taking part. However, it is not right to conclude that we cannot or must not provide any further information to these participants. Instead, we should aim to provide information but take care to do it sensitively and with appropriate oversight and guidance, including from independent ethics committees.

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In putting together this guidance, we have found evidence that participants who stop taking part early might be less likely than those who ‘complete’ a study to receive important messages at the end of the study, such as appreciation for having taken part, and information about how and when the study results will be made available. This may in part be due to uncertainty or confusion about whether it is acceptable to communicate with participants after they have ‘withdrawn’ from a study.

Providing no further information means participants do not get information that they want to have and may end up feeling ‘abandoned’. In modern research ethics, it is widely accepted that research participants have the right to withdraw their informed consent at any time and without negative consequence. We suggest that withholding information that participants want or need after they stop participating in a study could be considered a negative consequence of withdrawing informed consent, and therefore is not compatible with this ethical standard.

How should this document be used?

This document supports researchers through a comprehensive process to produce patient-facing materials specific to their study.

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We aimed to make guidance that can apply to many different types of research study, including clinical trials and other medical research. We are conscious that there can be no ‘one size fits all’ approach to this, so an important step in preparing participant information for a given study is to consider the specific study, its participants and their ‘pathway’ through the study (an example pathway is given on the Appendix page). An important part of the process is also to factor in what is known about each participant’s specific circumstances.

In the other sections of this guidance, we describe a general process for planning and drafting written communications for participants who stop taking part in research early. This includes specific topics to cover in the communications and, where it might be helpful, examples of ways to present or word certain topics. We have also provided explanations for the inclusion of some topics, which could be useful in justifying the approach to others.