Document Author List
Liam Bishop, William Cragg (project lead), Rachael Gilberts, Michael Gregg, Mary Mancini, Terry Lowden, plus others (not named).
We would like to thank all everyone who contributed to this work by reviewing topic lists, more generally by discussing the project and the issues it raises, and through providing support and assistance in various other ways.
This project was funded by the National Institute for Health and Care Research (NIHR) CTU Support Funding scheme. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
How this document was developed
This guidance was developed in three stages. First, we carried out a scoping literature review to find previously published reports about the process of participants stopping their participation early, or otherwise mentioning information topics to provide to research participants at the end of their time participating (whether they stop early or at the originally planned time). The results of the literature review were summarised into a single ‘topic list’ of information topics or items to potentially provide to research participants who stop taking part in studies early. This topic list was reviewed by a group of interested researchers and patients to help prioritise the topics, suggest any items that might be unnecessary or any that might be added.
Next, a series of discussion meetings were held for a group of patients and researchers to discuss the idea of researchers providing information to research participants who stop taking part early. This included reviewing the topic list mentioned above, discussing which information topics might be most important, how they should be communicated and by whom. The project lead amalgamated these discussions into a first draft of this guidance, and all group members were given a chance to review and feed back on this.
Finally, a separate, larger group of patients was asked to review the draft guidance, feeding back on any aspects they wanted, with some guidance questions to answer if they helped guide their review. The final guidance, incorporating this additional feedback, was agreed collectively by the main guidance development group.
Research ethics commitee member survey
In 2022-23 we are running a short survey to get the views of ethics committee members on our guidance and the issues it raises. You can access a copy of the survey protocol here.