Abstract
Background: Data sharing enables researchers to conduct novel research with previously collected datasets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing, even de-identified, quantitative data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to sharing quantitative data remain, there are additional challenges for sharing qualitative data in trials. Incorporating the necessary information about how qualitative data will be shared into already complex trial recruitment and consent processes proves challenging. The aim of this study was to explore whether and how trial teams share qualitative data collected as part of the design, conduct, analysis, or delivery of clinical trials. Methods: Phase 1 involved semi-structured, in-depth qualitative interviews and focus groups with key trial stakeholder groups including trial managers and clinical trialists (n=3), qualitative researchers in trials (n=9), members of research funding bodies (n=2) and trial participants (n=1). Data were analysed using thematic analysis. In Phase 2, we conducted a content analysis of 16 participant information leaflets (PIL) and consent forms (CF) for trials that collected qualitative data. Results: Three key themes were identified from our Phase 1 findings: ' Understanding and experiences of the potential benefits of sharing qualitative data from trials', 'Concerns about qualitative data sharing', and ' Future guidance and funding'. In phase 2, the PILs and CFs received revealed that the benefits of data sharing for participants were only explained in two of the study documents. Conclusions: The value of sharing qualitative data was acknowledged, but there are many uncertainties as to how, when, and where to share this data. In addition, there were ethical concerns in relation to the consent process required for qualitative data sharing in trials. This study provides insight into the existing practice of qualitative data sharing in trials.
| Original language | English |
|---|---|
| Article number | 10 |
| Number of pages | 17 |
| Journal | HRB Open Research |
| Volume | 6 |
| Early online date | 6 Feb 2023 |
| DOIs | |
| Publication status | Published - 13 Jul 2023 |
Bibliographical note
Grant information: The work is funded by the Health Research Board-Trials Methodology Research Network Ireland award [HRB-TMRN-2017-1]. KMS is supported by a HRB Applying Research into Policy and Practice Fellowship (HRB-ARPP-A-2018-011). MRS is supported by an MRC grant (MC_UU_00004/08). KG is supported by a Chief Scientist Office of the Scottish Governments Health and Social Care Directorate (CZU/3/3)The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Data Availability Statement
The purpose of our study was to explore whether and how qualitative data is shared within trials. Before the completion of the study, we felt it would not be appropriate to share raw data collected for this study and therefore did not obtain consent to do so. We used NVIVO coding queries function as advocated by Tsai et al. (2016) to facilitate transparency and the credibility of our analysis (Houghton et al., 2013) (See Table 2). The data cannot be shared via an alternative route of closed access, as we did not gain consent for others, beyond the research team, to access the data. Readers who wish to ask questions about the data can contact Catherine Houghton who can provide a visual overview of the analysis as opposed to sharing the raw transcripts. We can also offer partial access to the PILs and CFs analysed in this study on request.Extended data:
Open Science Framework: Qualitative data sharing practices in clinical trials in the UK and Ireland: Towards the production of good practice guidance. https://doi.org/10.17605/OSF.IO/BKC8D (Houghton et al., 2021).
This study contains the following extended data:
• Appendix 1: Recruitment emails
• Appendix 2: Participant Information leaflets
• Appendix 3: Informed consent form
• Appendix 4: Distress Protocol
• Appendix 5: Focus group Interview guide
Data are available under the terms of the https://creativecommons.org/licenses/by/4.0/legalcode. (CC-BY 4.0)
Keywords
- qualitative
- data sharing
- trials
- focus groups