Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance

Phase 1

Study design. This study employed a qualitative descriptive approach using thematic analysis of data (Braun & Clarke, 2006). This approach explores general beliefs and views that expose the experiences described by target populations (Al Dandan et al., 2019). The perspectives and beliefs of participants were gathered using semi-structured focus group interviews via Zoom video conferencing platform.

Recruitment. We aimed to recruit approximately 30 individuals who had experience of qualitative data in clinical trials either as researchers, participants in trials, or as funders reviewing grant applications for clinical trials. Participants were recruited by contacting the UK Clinical Research Collaboration (UKCRC), Irish Clinical Research Facilities (CRF) and through Health Research Board Trials-Methodology Research Network (HRB-TMRN) and MRC-NIHR Trials Methodology Research Partnership (TMRP) networks. This sample size was chosen in line with guidance from Vasileiou et al. (2018) regarding ‘data adequacy’, whereby we aimed to have sufficient data for meaningful analysis by capturing the perspectives of those involved in qualitative research in clinical trials. We asked the individuals who were responsible for managing the networks social media platforms to circulate a recruitment email through their respective mailing lists and social media channels.

Once prospective participants expressed an interest, they were sent the PIL and were required to complete an online CF prior to their focus group and/or interview. All participants were informed of the interview procedures and the recordings at least one week in advance of the research study. Participants were provided with contact information for the research assistant (MMC) if they had any questions in advance, and it was emphasised that consent in the research study was completely voluntary. Informed consent was obtained prior to any data collection. As the focus of our research was to determine whether and how qualitative data should be shared, we therefore did not ask for consent to share the raw data for this study.

We obtained approval for this study on the 17/02/2021 by our local Research Ethics Committee. REC number: 2021.01.009. All study materials can be found as Extended data (Houghton et al., 2021).

Data collection. This study employed online methods of data collection as face-to-face contact was not possible due to coronavirus disease 2019 (COVID-19) restrictions active at the time, and virtual focus groups offered the opportunity to bring people together who were not geographically co-located. Focus groups and interviews were conducted virtually using a secure Zoom video conferencing account and were audio-visually recorded. All interviews and focus groups were conducted by experienced qualitative researchers (CH and LB). CH is co-chair of Qualitative Research in trials Centre (QUESTS) embedded within the HRB-TMRN and is a senior lecturer in the School of Nursing and Midwifery in University of Galway. CH has extensive experience in, and has published on, qualitative methodology, qualitative evidence synthesis (QES) methodology, data collection, ethics, rigour, paradigms and analysis in qualitative research. LB is also a senior lecturer in the School of Nursing and Midwifery in University of Galway. LB is co-lead of the QES strand within ESI and her QES portfolio lies in advancing the synthesis on recruitment to trials in healthcare. Participants were made aware that focus group data could not be withdrawn once the interview was finished, but they were not obliged to answer certain questions if they were not comfortable doing so. Participants were also given the option of participating in an individual interview where participation in a focus group was not feasible. Participants did not have any relationship established with the research team members prior to study commencement. Participants were informed about the research purposes during preliminary contact, through the information leaflet and when informed consent was obtained.

Data were collected between May 2021 and July 2021. We developed a semi-structured interview guide for both the interviews and focus groups (see Supplementary File 5) that explored perspectives of sharing qualitative data collected within trials, potential benefits, and challenges of same, and recommendations for what guidance is needed to support those involved in sharing qualitative data in trials.

Data analysis. We analysed the interview data using thematic analysis (Braun & Clarke, 2006). Thematic analysis is an inductive approach to analysis, going beyond description into interpretation thus telling a coherent story about what is going on in the data (Clarke & Braun, 2018, p106). Thematic analysis was conducted in line with the six key steps outlined by Braun and Clarke.

The research team agreed the coding and theme development from the qualitative phase to ensure the data was represented sufficiently in the developed themes which helped minimise researcher bias. The analysis was conducted by CH and MMC, supported by MD and LB and managed within QSR NVIVO version 12 to provide a transparent audit trail of the decisions made through the analysis (Houghton et al., 2013). The coding was an iterative process, and CH along with other members of the research team including MD and LB moved between the transcripts and the codes created. MD and LB also offered feedback on interpretations of the data and encouraged reflexivity. A codebook was created within QSR NVIVO to exhibit the reliability and credibility of our findings.

Phase 2

Study design. A content analysis of PILs and CFs was conducted for qualitative data collected as part of the conduct of clinical trials.

Data collection. We contacted trials managers and individual researchers involved in using qualitative data in trials and the UKCRC, Irish CRF, HRB TMRN and MRC-NIHR TMRP networks to gather PILs and CFs related to qualitative components in trial. A purposive and convenience sampling method was used to collect the study documents (i.e., the PILs and CFs). A tailored data extraction form (Table 1) was developed to extract information such as whether specific clauses for data sharing are included in the CF.

Data analysis. Content analysis was used to analyse whether and how consent was being obtained for qualitative data sharing (Elo & Kyngäs, 2008). Content analysis is a valuable method for analysing qualitative material and seeks to analyse data in view of the meanings someone attributes to them (Krippendorff, 2018). This provided baseline information on the prevalence of qualitative data sharing as well as the strategies being employed to do so. We also analysed the purpose for which the sharing of qualitative data was being requested. For this reason, we analysed the PILs and CFs for each study together for cohesion across the informed consent process.

Phase 1

We conducted four focus groups and three individual interviews with key stakeholders (n=15): 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) who have been involved in qualitative research. The majority of the participants were from the UK (n=12) and the remainder were Irish (n=3). Almost all the participants were female (n=13, male n=2). Focus groups one and two were conducted with qualitative researchers in trials (n=6). Focus group three was conducted with clinical trialists or trial managers (n=3). Focus group four was conducted with a trial participant (n=1) and members of research funding bodies (n=2). All three individual interviews were conducted with qualitative researchers (n=3). Collecting interview and focus group data arising from discussion amongst participant groups added to the variation and depth of the overall data. The interview duration ranged from 25–60 minutes. All efforts were made to ensure that all participants of the focus groups were asked the same questions as the individual interview participants, thus ensuring a pragmatic and consistent approach to data collection. Three key themes were identified from our findings. Firstly, Understanding and experiences of the potential benefits of sharing qualitative data from trials explores participants’ perceptions of why data sharing in trials can be useful and their experience of data sharing practices. The second theme, Concerns about qualitative data sharing, examines the ethical issues and potential loss of context through pseudonymisation. The third theme, Future guidance and funding, describes how qualitative data sharing in trials can be better supported.

Understandings and experiences of the potential benefits of sharing qualitative data from trials. This theme explores participants’ general understanding of data sharing and their own experience (if any) of data sharing. For many, their views were based on knowledge of, rather than experience of, data sharing.

Participants described their understanding of data sharing as the sharing and reusing of data outside of the research team for future research purposes:

Many participants did not have much experience in data sharing and had very limited experience of qualitative data sharing in trials. For participants who did have experience of data sharing, this was often in the context of quantitative data sharing:

Participants recognised how valuable qualitative data are in the context of trials and often felt that better use of their data could be made:

Many participants identified the benefits of qualitative data sharing in trials so that it can be used for other purposes, which included enabling other researchers to use it to help answer different research questions. They also recognised that data sharing for multiple purposes provides additional benefits by helping to reduce research waste for trials:

From a funder perspective, reducing research waste in trials had positive financial implications also:

Sharing qualitative data in trials does not only have benefits for researchers but also provides opportunities to benefit research participants generally and patients in particular:

Similarly, from the perspective of the trial participant:

For some researchers, there was a sense of duty to give something back to research participants who have provided time and energy into contributing to the trial. Many participants recognised the benefits of data sharing in trials to help reduce the burden placed on participants, particularly in relation to those who may have rare diseases, which may be over researched:

Similarly, another aspect of qualitative data sharing is that it could potentially enhance participation to a trial by reducing patients being asked repeatedly for the same information:

In summary, while experience of sharing qualitative data in trials was limited, there was recognition that it could have potential benefits in terms of secondary analyses of qualitative data and making the most of available data to answer new questions and reduce research waste. However, the actual process of sharing qualitative data generally and in the context of trials did cause some concern and this is examined in the next theme.

Concerns about sharing qualitative data from trials. This theme explores concerns raised by interviewees around qualitative data sharing in trials, primarily in the “how to share”, ethical considerations and the possibility of losing context through pseudonymisation.

While participants recognised the value of sharing qualitative data in trials, they did not know how or where to share their data. Participants felt that discussions around the sharing of qualitative data in trials were becoming more common, participants also highlighted the need to discuss further how to share qualitative data in trials:

Many participants expressed concerns in relation to the practical aspects of how they can generally share their qualitative data:

For some researchers, there is no system or process for identifying qualitative data that can be accessed for secondary data analysis

Participants spoke about their institutions’ data sharing approaches and/or policies. One participant spoke about the controlled access data sharing policies in their unit and highlighted the possible issues with sharing qualitative data through a repository:

Participants were often concerned what would happen if there were inadequate data protection controls in place which affected their choice and ability to share their qualitative data in trials:

While, many participants highlighted the importance of data sharing, they also recognised that data sharing may need a nuanced approach which may not always be feasible:

In terms of ethics, many participants expressed views on the rigorous consent process required for qualitative data sharing in trials. One trial participant explained the detailed and long-winded process involved in giving their consent for a trial and for further use of their data:

Obtaining informed consent was viewed with high importance by participants. Many spoke about the importance of making sure that research data can be made available for future reuse, and as such it was essential to seek consent for future reuse of research participants’ data.

The complex and challenging consent process was also discussed in the context of how time consuming it can be when preparing to share qualitative data from trials:

It was also recognized that qualitative data sharing poses special structural challenges for ethical data practices within trials. for example, a challenge in one trial was in relation to receiving ethical approval for participants who registered and consented to participate but refused to be randomised:

While many participants identified concerns in relation to seeking consent and ethics, they also recognised that there have been considerable improvements in the quality and content of documents such as consent forms.

Participants also mentioned that governance has strict guidelines in relation to data sharing which they must abide by, particularly in relation to ensuring pseudonymisation (often referred to by participants as anonymisation) of research participants:

While the importance of pseudonymisation was understood, some participants had concerns about losing context through this process. Several participants referred to the importance of anonymising raw transcripts to remove any identifiable information. It was important that the study participant could not be identified but also certain events, trial sites or clinical settings. There was a concern that participants may not be as open and honest when being interviewed if they knew that their full transcripts would be shared:

The pseudonymisation of qualitative data would be easier for large multiples site trials, but in smaller or single site trials or trials with a particular context, for example rare diseases, it may be more challenging to pseudonymise. Many participants discussed the importance of context in qualitative research; and that important context could be lost through pseudonymisation:

For one researcher who had previously shared qualitative data from trials, it was important to provide some context to make the analysis meaningful. Using a controlled access approach to sharing would enable this:

Similarly, broader sharing outside of agreed teams was considered potentially difficult due to lack of context, and this was of particular issue when conducting qualitative research in large complex trials:

It was acknowledged by some participants that qualitative researchers can be quite protective of the primary participants, and data that has been generated through developing a unique relationship between researcher and participant.

In summary, many of the concerns identified centred around uncertainty and need for guidance around qualitative data sharing generally and in the context of trials. The need for guidance is explored further in the next theme.

Future guidance and funding for sharing qualitative data from trials. This theme explores the issues around guidance and funding for qualitative data sharing purposes in trials. Across the focus groups, many participants expressed concerns over the lack of guidance and funding available for qualitative data sharing aspects in trials.

Many participants shared their worries about an absence of clear standards and established guidelines explaining where, when and how to share qualitative data from trials. This issue was at the forefront of many participants experiences:

An urgent need for clear guidance and good practice when pseudonymising qualitative data from trials was highlighted:

For some, guidance in the format of clear and practical examples of supporting documents such as CFs and PILs would be extremely helpful and valuable to enable the process of qualitative data sharing from trials. Sample consent forms were identified as a practical resource to help guide researchers in the right direction:

While many participants expressed a great need for clear guidance for trials, others felt that there may already be guidance in place that specifically addresses qualitative data sharing in the context of trials. However, they did not know where to look or who to turn to for guidance:

Moreover, many participants identified the importance and necessity of planning for data sharing from the beginning of the trial design. Participants recognised that planning for qualitative data sharing is not always easy and data sharing can often be a complex process:

In addition to the need for clear and practical guidance, participants expressed a need for the availability of sufficient funds for the sharing of qualitative data. This was particularly in the context of pseudonymising data such as interview transcripts which is time consuming and has resource implications for the funding of data sharing. For some, the sharing of qualitative data would not be possible without sufficient funds and resources:

Participants also recognised the additional time involved in the thorough pseudonymisation of qualitative data and some identified that this needs to be considered in advance of applying for and writing grant applications.

In summary, participants called for easily accessible guidance and resources for how best to share qualitative data in trials. They also felt the cost and time of data sharing process need to be acknowledged through funding.

Phase II

Overall, 16 PILs and 16 CFs were received from clinical trial assistants, qualitative researchers in trials, clinical trialists and trial managers. Feasibility trials, treatment trials, screening trials and prevention trials were among the types of clinical trials conducted. The PILs indicated that the trials were broadly conducted to: evaluate treatment interventions for diseases and conditions (i.e., multiple sclerosis); explore supportive care interventions and/or programmes for chronic illnesses (i.e., cancer) and to assess ways of preventing diseases and conditions (i.e., stress and anxiety). 11 PILs and CFs were from the UK and five PILs and CFs were from Ireland. All the Irish trials were funded by the Health Research Board (HRB) and the UK trials were funded by the National Institute for Health Research (NIHR) and the Medical Research Council (MRC). Whether the documents indicated the purpose of the research, the consent process and how confidentiality will be protected was recorded and is shown in Table 1. The benefits of data sharing for participants were only explained in two of the study documents i.e., the benefits of data sharing in making research more accessible to patients. All documents described the plans for future publishing. Similarly, 13 of the 16 documents indicated how data will be used in future publications. For example, one PIL stated: “When all the interviews have finished, we will write up the information and publish it in scientific journals.” (Study 15).

In total, 8 of the study documents specified the conditions under which access to the data may be granted to others directly related to the research project. For example, one consent form stated: “I give permission for the interview to be audio recorded and for the transcriber and delegated members of the research team to have access to the audio recording, or transcription of it, and understand that my confidentiality will be maintained” (Study 1).

Of the 16 study documents, 15 indicated how data will be de-identified in practice. For example, one PIL stated: “We will then replace your name with a code and store your name separately from your other information (data). Only the researcher will hold the key to the code. The researcher will enter the information that you provide on a password-protected computer using your code” (Study 2). Six of the study documents also described the process for deleting data if a participant wished and 12 of the study documents outlined when the retention of personal information expired.

Information regarding the qualitative data being available in a repository was only specified in one study document. Overall, 11 of the study documents indicated whether qualitative data could be used for future research. For example, one CF outlined: “I understand that the information collected about me may be used to support other research in the future and may be shared anonymously with other researchers” (Study 1).

Strengths and limitations

To the best of our knowledge, this study provides the first account of views and experiences of clinical trialists, trial managers, qualitative researchers, funders, and trial participants about sharing qualitative data in trials. While a few other studies have explored views and experiences of qualitative data sharing among researchers (Mozersky et al., 2020), we believe ours is the first to explore views and experiences of qualitative data sharing in the context of trials among trialists, trial managers, qualitative researchers, funders, and trial participants. The findings of our study have implications for qualitative researchers more broadly given the international shift towards sharing qualitative data, which has historically not been shared. A key limitation of our study was the sample size which may affect the transferability of our findings. We aimed to recruit approximately 32 participants, however, only 15 participants were recruited across the focus groups and interviews. It is also recognised that most research participants in this study were qualitative researchers (n=9). Further research is therefore needed with members of research funding bodies, trial managers, clinical trialists and participants who have participated in a clinical trial. Moreover, we only interviewed one trial participant, which may be attributed to our online recruitment strategy due to COVID-19 restrictions. Due to COVID-19 restrictions, in person-centred recruitment strategies appeared challenging, primarily due to data protection concerns. Thus, we opted for a virtual recruitment approach which may have not been as inclusive and engaging for trial participants who had been involved in a qualitative study. However, few studies have found that conducting qualitative research virtually can be just as effective as in person (Keen et al., 2022). In addition, we recognise that the sample size of sixteen study documents (PILs and CFs) is small. However, these documents were only intended to give an indication of the current consent procedures for qualitative data collected as part of the conduct of clinical trials. In addition, the informed consent procedures for the included studies were not linked with study participants so we were unable to conduct any comparative analyses across Phases 1 and 2. Finally, the purposive and convenience sampling method used to collect the documents in this study may have led to an enthusiasm bias. Therefore, investigators interested in qualitative data sharing, and better alignment with good practice, were probably more likely to contribute documents.