Welsh Government commissioned the National Centre for Social Research (NATCEN) to conduct a deliberative public dialogue exercise to explore views on the use of health data for identifying and approaching individuals about research studies that may be relevant to them, without prior consent.
The exercise involved 35 participants in Wales, engaging with researchers across 4 sessions (3 online, 1 in-person) including a full day deliberation session. The report of the exercise concluded that recruitment processes reliant on un-consented patient data to identify and approach people for research studies could be deemed to satisfy a broad constituency within the dialogue, provided conditions were met. These conditions were broadly grouped into categories including: effective oversight, focus on quality of research and equality of access to studies; demonstrating public benefit; effective public consultation on plans for such services; and transparency of processes and uses.

Why was the work needed

Data that is routinely collected as part of day-to-day operation of NHS services has the potential to be very useful to supporting research delivery. Traditional processes for recruiting to studies tend to rely on manual data searches, or focusing on NHS settings where high foot-fall of patients offers the best chance of recruiting the numbers of individuals needed for a study. Using data to identify and support methods of contacting individuals about studies offers the possibility of more efficient and effective recruitment approaches. Some research services, such as NHS Digitrials and CPRD, are already using data to facilitate the identification and approach of potential participants, but they operate in different ways and have certain limitations. Furthermore, during the Covid-19 pandemic, exemptions to normal information governance processes established an alternative model for using data to identify and approach individuals for research (in this case, for Covid-19-related studies), that has sparked conversations about the practicality of continuing such approaches.

It was felt that specific public engagement work is required to provide evidence on public expectations that can underpin future policy development around services that use data to identify and approach individuals about research studies that may be relevant to them.

What happened

Drawing from the NatCen panel – a random probability sample of over 22,000 people from across the UK – 35 Welsh participants were purposively recruited for the dialogue, reflecting a range of demographic characteristics and backgrounds. Participants were given briefing materials to ensure everyone was deliberating from a shared evidentiary basis, and throughout the dialogue, participants were briefed by, and had opportunities to put questions to, a range of expert speakers. The dialogue was split into four sessions. The first three, which were online, each lasting 2.5hrs, were designed to introduce participants to key elements of the processes used by UK health services to identify and approach prospective research study participants, and the role that health data has played, and could play, in those processes. The fourth, deliberative session was an all-day face-to-face event, in which participants were split between two locations: Bangor and Cardiff. During this final session, participants engaged in a series of scenario exercises:

  • The first scenario encouraged them to think about the relative importance of diversity, equity, and inclusion in processes that rely on patient health data to identify and approach people about research studies.
  • The second explored participant views on the role and status of personal autonomy in such processes, and how patient privacy and confidentiality ought to be balanced against patient and public benefits.
  • The third asked participants to assess a particular digital process for identifying and inviting people to take part in health-related research, and to decide whether they would be comfortable with a process that relied on accessing health data without prior consent.
  • In the final exercise, participants developed and voted on a set of expectations regarding future processes for identifying and approaching prospective research study participants in Wales.

A flowchart showing the methodology behind the public dialogue approach

 

What were the benefits

This work enabled a detailed exploration of individuals views on the use of data for specific research related purposes, and how people balance the trade-offs between potential benefits and harms. How data can be accessed, by whom, and in what circumstances, are complex issues guided by various legislative and information governance requirements. Undertaking a focused piece of dialogue work enabled participants to be briefed on the relevant factors by a range of experts, including those who have concerns about the implications of these types of data access tools.

The outcome of the work provided a rich, detailed analysis of how individuals weigh up the pros and cons, and their expectations and conditions for any future use of data services that access health data for identifying and approaching individuals about research studies.

What type of data was involved

The focus of the dialogue exercise was how identifiable data from the health service could be accessed for identifying and approaching individuals without prior consent.

The NATCEN team collected primary data as part of the exercise, including pre and post exercise survey data on general opinions, as well as verbatim transcript data from all the deliberative sessions.

Who funded and collaborated on the work

Welsh Government funded the work, designed and delivered by NATCEN. The Wales Data for Research Working Group provided a sounding board for Welsh Government policy colleagues and NATCEN team, providing advice and direction on the scope, design and delivery of the work. The Data for Research Working Group includes representation from data research academics, NHS data management and information governance experts, NHS research delivery staff, primary care practitioners, Welsh Government data policy officials and lay members.

Colleagues from Understanding Patient Data, UseMyData, MedConfidential, Ada Lovelace Institute, Oxford University and Cardiff University contributed to the dialogue exercise as ‘expert witnesses’.

Where can I get more info

The report and accompanying materials can be found on the Health and Care Research Wales website here.