Implications of the survey findings
The results of our survey suggest that the idea of trialists giving information to trial participants when they stop taking part may be acceptable to many REC members. We will continue to learn more about ethics committee views as we put our guidance into practice, but we hope that, for now, the data presented here will reassure trialists that ethics committees support end-of-participation communications if they are prepared in line with our guidance. We have nonetheless refined our guidance based on the survey results, to more directly address some of the concerns raised.
Survey respondents highlighted some challenges and complexities in doing this sort of communication, and the need for caution to mitigate the risk that participants feel pressured by receiving the communication. We agree with these points, and we had already considered them during development of our guidance. The example wording in our guidance was developed with and by public contributors, and was designed to inform but not put pressure on participants. In our suggested process for developing a communication strategy and materials, we emphasise involving public contributors in the process, considering the needs of the participants in the specific study, and assessing each participant’s circumstances before making contact.
Some respondents suggested an end-of-participation information sheet should only be given if participants have consented to receive it. We agree that participants should have choices about how much information they get, and should not be surprised by receiving an end-of-participation communication. We also agree with the need to respect individual participants’ wishes for no further contact at all, when they have said (or implied) that this is what they want. However, we suggest that it would cause problems to ask for participants’ consent to receive the information as part of their original consent to take part. If a participant gave that consent but then later said they wanted to stop taking part in the trial – i.e. they withdrew their consent – it might be difficult to know if the original consent to receive the information still stood, or if it had also been withdrawn when they stopped taking part. See PeRSEVERE project guidance around consent for more about this sort of issue [3].
Although only a small proportion of all REC members completed the survey, we had responses from members of RECs across the UK, a sizeable number of REC chairs and mixture of lay and expert members. Although we cannot say if those who did not take part have substantially different views on this topic, in terms of age, gender and ethnicity, the respondents broadly seem to match the overall population of REC members.
Most respondents had not been asked to review end-of-participation communications before. Given the spread of responses from across different RECs, this seems likely to reflect the infrequency of the approach. It is hypothetically possible that researchers are using communication materials without informing RECs, but this seems unlikely given anecdotal evidence that trialists are cautious and tend to request REC review of participant-facing materials in case of doubt. This result therefore supports the conclusion that it is common for trial participants to receive limited or no information when they stop taking part. This aligns with our experience and with the previous lack of available guidance about end-of-participation communication. We suggest that the experiences of participants who stop taking part would be a good topic for future research, not only to improve those people’s experiences but potentially to improve the quality of clinical trials overall.
Our survey did not pose a direct question about whether REC approval for end-of-participation communications are needed or not, but it was possible for respondents to express this view via the ‘Other’ option. No respondents did this, indicating that all support our prior assumption that some REC oversight of end-of-participation communication is needed.
A substantial proportion of respondents accepted the idea of REC oversight only of template wording or even review only of the overall approach. This might suggest that these REC members are prepared to trust researchers to contact participants as they see fit. This may also reflect a recognition that RECs cannot feasibly oversee all participant communications. These findings align with recent reflective work from the HRA, where REC members favoured a focus on “fundamental issues, rather than being distracted by minor issues (such as phraseology)” [15]. A separate, Europe-wide study also highlighted REC members’ concerns about the amount of work potentially required for post-approval oversight activities, and about the potential for REC “overreach” and need for trust between RECs and researchers [16].
There is a general acceptance that participants can be supported by having information they might want or need readily available as they move through a study. This has been repeatedly highlighted via the NIHR Participant in Research Experience Survey [17, 18]. Putting this into practice will mean trialists wanting to do more participant communications. If they are under the impression that RECs need to approve all such communications, this might lead to an unmanageable workload for RECs, or trialists erring on the side of not sharing information that participants want or need because the need for REC review (or perceived need) is too big a barrier. We suggest that more guidance on this from HRA or others would be useful.
One further consideration in establishing such guidance may be that trials vary in terms of who is in direct contact with participants. In some cases, participants mostly interact with healthcare professionals and have no direct contact with the trialists at, for example, a clinical trials unit (CTU). Here, written communications between the CTU and participants might be quite rare, so it will be more feasible for REC to review all of them. Where participants are in direct contact with trialists, there may need to be various kinds of ad hoc communication (in both directions) and it does not seem feasible for REC to oversee it all.
Strengths and limitations
The strengths of our work are that it sheds light onto a previously underexplored topic, i.e. what REC members think about communication with participants who stop taking part and about REC review processes for participant communications in general.
One limitation not mentioned above is that we prioritised keeping the survey brief. There may therefore be more scope to explore this topic in more depth in future. Although we asked some current REC members to test the survey before we opened it to recruitment, there is some chance of some differences in interpretation, and we saw some evidence of this in the question about REC review. We believe this does not affect our overall conclusions. We initially planned to carry out a double-check on a proportion of the comment coding. This eventually proved infeasible due to limited resources, but we suggest this could not substantially affect our conclusions as the comment coding was only intended to explore perceptions alongside the quantitative survey questions.