8. Summary of recommendations

Recommendation 1

UKCRD Programme partners should explore consistent methods to record refusals to receive information about research options in electronic health records. These methods should be applied consistently across local, regional, and national systems, while recognising that patient comfort levels may vary depending on who is contacting them and how that contact is made.

Recommendation 2

UKCRD Programme partners should develop a plan for coordinated and extensive public communication about the use of patient information, setting out the arrangements in line with our guidance, to earn trust in the current safeguards. This plan should be UK-wide in scope, adaptable for devolved nation contexts, and overseen by a UK-wide steering group with representation from the HRA, the National Data Guardian, devolved administrations, and public contributors. Engaging and involving the public about their reasonable expectations about when research is care should also inform potential future developments. This should draw on factors influencing public acceptability from recent dialogues and require more safeguards for circumstances at the less comfortable end of the public acceptability spectrum. This plan should be supported by greater public communication about the value of research, and greater transparency when producing the results of research about the use of patient information (with specific information on the legal basis for that use).

The report recommends that future developments to provide clarity in this area, including any consideration of potential change in legislation to create legal gateways for access to patient data for recruitment purposes, should be founded on the premise of public acceptability and trust. This is because legal authority does not necessarily command social legitimacy. The report concludes that future decision-making about which next steps are right should therefore be shaped through the results of engaging and involving the public, drawing on UK-wide and devolved nation initiatives, with further testing and iteration in real-world settings before national adoption. Otherwise, it will have an adverse effect on public trust in research. UKCRD Programme partners should consider whether public surveys repeated over time and going forward could be used to show when the expectations of the public have changed (and what changes can be made in response to guidance) to make it easier to find and contact people about research in a new world of digital possibilities.

Recommendation 3

In line with wider policies on reducing the transfer of identifiable confidential patient information, UKCRD Programme partners should explore how sign-up registers could move towards using secure linkage to sources of relevant patient information instead of receiving bulk extracts of data at intervals.

Recommendation 4

UKCRD Programme partners should work with others, such as charities, to agree a common set of standards for consent (including historic consent) to link patient information for the purposes of contacting people about research, and a common definition of public interest. This work should involve the public to reflect people’s expectations. This group of organisations should also work with the public to agree standard statements to be used in future by sign-up registers, databases, and research studies.

Recommendation 5

UKCRD Programme partners should commission work with patients and the public to explore views on use of patient information for searching for potential participants, with a particular focus on people’s views about access to their patient information compared to receiving information about studies that may not be relevant due to broad search criteria.

Recommendation 6

UKCRD Programme partners should commission further work to explore the motivations of people who sign up to registers and their ongoing engagement needs, to understand and address any selection bias in sign-up registers.

Recommendation 7

UKCRD Programme partners should explore whether expanding the use of ‘Be Part of Research’ would increase public engagement with research, generate greater interactions between those who have registered and the service, and improve the quality of the data given by those that have registered.

Recommendation 8

UKCRD Programme partners should commission work to understand how researchers could make use of a single route to search for patients signed up to different sign-up registers, including where different registers hold different data fields. This work should explore the perspectives of patients and the public, and the value to them of different registers or routes of identification.

Recommendation 9

UKCRD Programme partners should consider both the mechanics of, and public perspectives on, dynamic consent when considering a subscription preference model.

Recommendation 10

The report concludes there is no breach of the common law duty of confidentiality in the specific context of identifying individuals who may be invited to take part in research where pseudonymisation or eligibility determination is carried out by a third party solely for the purpose of identifying potential participants for research and all of the following criteria apply:

• the identities of potential participants are only revealed to someone with a legitimate relationship;
• pseudonymisation or determination are undertaken using Privacy Enhancing Technologies (PETs) as described in section 6.8 of the Information Governance Review (2013);
• the process does not involve bulk extraction of data to the third party (such as onto an external database);
• in line with patients’ reasonable expectations, the processing must be carried out entirely within an existing clinical system whose primary purpose remains care; and,
• only the minimum necessary information should be accessed.

This reflects the original principles behind current policy in this narrow context. However, as this is not explicitly clear, risk-averse behaviour is limiting the use of this approach. The report recommends that DHSC explores whether there is a need to clarify this aspect of the Health Service (Control of Patient Information) Regulations 2002: to confirm that PET-enabled, in-system recruitment to research - meeting the above criteria - falls within scope where a relevant common law legal basis is met.

Recommendation 11

The UKCRD Programme partners should explore the potential for GPs to join a primary care digital intermediary meeting the standards in this report on an opt-out model rather than an individual sign-up model, to minimise the administrative burden of sign-up for both GPs and the digital intermediary.

Recommendation 12

UKCRD Programme partners should consider the language used in England to describe Secure Data Environments in the health context across the full range of research use cases. UKCRD Programme partners should consider whether the term ‘Secure Data Environment’ is appropriate for systems that allow researchers to analyse health and care information without receiving or seeing any identifiable confidential patient information. They should also consider how to clearly differentiate, in public-facing descriptions, between Secure Data Environment models used solely for anonymous data analysis and uses of data within a Secure Data Environment that can facilitate re-identification and contact but only via those in a legitimate care relationship with the patient. This recommendation is not intended to change the functionality that is being developed, but to reflect that patients might find it confusing to hear the same name for services that are intended to reassure the public that research is using non-identifiable data, and services that are used to find potential participants for research.

Recommendation 13

UKCRD Programme partners should support researchers to use people-centred principles when designing the models for finding and contacting people about research. This should include considering:

• how to balance the administrative ease of a high ratio of consented participants to people contacted against the risk of excluding people of relevance to the research,
• how national and local research delivery infrastructure supports researchers to reach a diverse population and to help potential participants to choose whether to take part in research, and
• how funders can make sure that search criteria should be designed to consider population diversity so that the results of studies can be applied to, and can help, all those who could benefit, as well as being conducted in an expedient and cost-effective manner.

Recommendation 14

UKCRD Programme partners should consider how research network staff, and NHS research delivery staff such as clinical research practitioners, could support central research teams by providing points of contact for patients who want to find out more about participating in a study that they have been informed about, particularly for industry studies where there is no central research team.