Cragg, W.J. orcid.org/0000-0002-1274-8521, Bishop, L. orcid.org/0000-0003-0890-2423, Gilberts, R. orcid.org/0000-0003-3326-7900 et al. (3 more authors) (2024) Views of research ethics committee members on end-of-participation communications for trial participants who stop taking part: a cross-sectional survey study. Trials, 25. 636. ISSN 1745-6215
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
Keywords: | Participant withdrawal, Participation changes, Participant communication, Ethics review processes |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Inst of Clinical Trials Research (LICTR) (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 22 Jan 2025 15:55 |
Last Modified: | 22 Jan 2025 15:55 |
Published Version: | https://trialsjournal.biomedcentral.com/articles/1... |
Status: | Published |
Publisher: | Springer Nature |
Identification Number: | 10.1186/s13063-024-08465-3 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:222066 |