Views of research ethics committee members on end-of-participation communications for trial participants who stop taking part: a cross-sectional survey study.

Abstract

Background Giving information to trial participants who stop taking part could support them through what can be a difficult process. We previously developed guidance around the ethical acceptability of such information provision, and about how trialists can develop suitable communication materials. There is limited evidence about what research ethics committees think of this issue, and limited guidance about what level of oversight they should have over the proposed communications, or post-consent participant communications generally. We conducted a survey of UK ethics committee members to address these points. Methods The survey was co-developed by public contributors and trialists who had previously worked together on the communications guidance. We asked respondents if they agreed with the general idea of informing participants who stop taking part, if they had ever been requested to review similar communications, and what level of ethics committee review they might recommend. The survey was primarily conducted online. It was reviewed by three ethics committee members before finalisation and shared directly with all UK ethics committee members. We analysed quantitative questions descriptively and used inductive analysis for open questions to identify common themes. Results Ninety-one ethics committee members participated (nearly 10% of all UK members). The sample was similar to reported data about all members in terms of several personal characteristics. Most respondents (83%) agreed with our project's rationale. Only 23% of respondents reported having been asked to review an end-of-participation information sheet before. Respondents gave various answers about the level of ethics committee review required, but most supported a relatively proportionate review process. Common concerns were about the risk of coercion or making participants feel pressured. Conclusions Our survey suggests that ethics committee members generally support providing information to trial participants who stop taking part, if risks to participants are mitigated. We believe our guidance already addresses the main concerns raised. Our respondents’ lack of prior experience with end-of-participation information sheets suggests that participants are not getting information they want or need when they stop participating. Our results help clarify how ethics committee should oversee post-consent participant communications, but further guidance from research regulators could be helpful.