How can we support research participants who stop taking part? Communications guidance developed through public-researcher collaboration.

ABSTRACT

BACKGROUND: Research study participants can stop taking part early, in various circumstances. Sometimes this experience can be stressful. Providing participants with the information they want or need when they stop could improve participants' experiences, and may benefit individual studies' objectives and research in general. A group of public contributors and researchers at the Clinical Trials Research Unit, University of Leeds, aimed to develop a communication template and researcher guidance. This would address how to provide information sensitively around the time when participants stop or significantly reduce their level of participation. METHODS: The project lead used scoping review methods to identify relevant prior evidence and derive a list of potential information topics to communicate to participants who stop taking part. The topic list was reviewed by research professionals and public contributors before finalisation. Further public contributors were identified from a range of networks. The contributors formed a 'development group', to work on the detail of the planned resources, and a larger 'review group' to review the draft output before finalisation. The involvement was planned so that the development group could shape the direction and pace of the work. RESULTS: The literature review identified 413 relevant reports, resulting in 94 information topics. The review suggested that this issue has not been well explored previously. Some evidence suggested early-stopping participants are sometimes excluded from important communications (such as study results) without clear justification. The development group agreed early to focus on guidance with reusable examples rather than a template. We took time to explore different perspectives and made decisions by informal consensus. Review group feedback was broadly positive but highlighted the need to improve resource navigability, leading to its final online form. CONCLUSIONS: We co-developed a resource to provide support to research participants who stop taking part. A strength of this work is that several of the public contributors have direct lived experience of stopping research participation. We encourage others to review the resource and consider how they support these participants in their studies. Our work highlights the value of researchers and participants working together, including on complex and ethically challenging topics.

Participants in research sometimes stop taking part early. This can sometimes be stressful or difficult for them. Giving them information they want or need around that time could help them and the research. Public contributors and researchers worked together on this project. We wanted to help researchers get information to research participants who stop taking part. Some of the public contributors had experiences of stopping research participation early.The project lead first made a rough plan for the project, with public contributors' help. He left the plan open so the public contributors could help shape the project. The project lead searched for relevant information in published literature. This search showed there has not been much work before on how to help participants who stop taking part. He used the search results to make a list of topics that could be useful to give participants who stop taking part. He asked public contributors and researchers to review the list.Public contributors then joined one of two groups. A smaller group worked on the detail of the planned guidance. A larger group reviewed the draft guidance.The smaller group worked together to make the final guidance in six online meetings. The guidance includes example wording for others to use in their own participant communications. The reviewer group generally liked the guidance but had comments on making it easier to use. The final resource is available online and a link is in the references to this article.