Care Home Data Review - Full Report

Care Home Data Ethics

The data that is generated through the delivery of social care provides a wealth of opportunities for research and innovation. Research and innovation can improve our understanding of: care and support needs; the delivery of care and support; the development of new services; progress towards reducing inequalities of access, experiences and outcomes. However, these opportunities can only be realised if there are clear and timely information governance and ethical routes for accessing, collecting, and using data appropriately.

Data Ethics: An emerging branch of applied ethics that studies and evaluates moral problems and describes the value judgements related to data in order to formulate and support morally good solutions.

The aim of data ethics is to promote responsible and sustainable use of data for the benefit of people and society and ensure that knowledge obtained through data is not used against the legitimate interests of an individual or group while identifying and promoting standards, values and responsibilities that allow us to judge whether decisions or actions are appropriate, ‘right’, or ‘good’.

Source: Data Ethics Framework: glossary and methodology - GOV.UK (www.gov.uk)

Information governance and ethical use of data are closely related. Due to the complexities around information governance and ethics, for the purposes of this review, care home data information governance is considered in the Data Sharing chapter. In this chapter, we set out a summary of the review findings from our consideration of the ethical review processes for (adult) care home data (also applicable for adult social care data more broadly) for its use in research, innovation and statistics. A more in-depth paper about the social care data ethics landscape in Scotland and some of the gaps is available on the Care Home Data Review webpage. Much of the evidence presented in this chapter and in the more in depth paper are sourced from the GEARED UP project^[46].

Ethical approach

The Health and Social Care Data Strategy^[47] sets out the ethical approach and principles to using all health and social care data in Scotland. The Strategy states that “we want to embed an ethical, open, and human rights-based approach to the use of health and social care data in Scotland which maintains public trust and confidence.” The Strategy outlines the principles for the collection and use of health and social care data.

Table: Principles for data collection and use

Principles

Beneficial: Start with a clear articulation of need, public benefit, and risks.

Responsible: Recognise the need to behave in a trustworthy way with the use of data and digital technology across systems and processes.

Accountable: Be accountable and transparent to independent scrutiny and oversight, use reliable practices and work within our skillsets.

Insightful: Our health and social care data contain insights that can help us improve services. However, we must identify where there are limitations in the data and digital technology being used, and recognise unintended bias, while identifying and ensuring that approved mitigations are in place.

Inclusive: Ensure that data is accessible in formats that are appropriate for everyone.

Necessary: Identify reasonable and proportionate requirements to meet the need.

Observant: Implement all relevant legislation and codes of practice (for example around the general ethical principles of informed consent, confidentiality & anonymity, avoiding harm to data subjects / participants and researchers).

Widely Participatory: Embed the view of the public, through the routine use of public participation and co-design.

Source: Scottish Government (2023) Health and Care Data Strategy

Applying ethical approaches and principles to care home data processing are core to all the Care Home Data Review recommendations and subsequent work programmes.

Ethical review

Collecting, analysing or linking data can sometimes involve a degree of ethical risk, and/or involve additional burdens or intrusions exceeding those involved in providing normal care^[48]. Social care research often focuses on vulnerable populations, including older people, individuals with disabilities, or those facing mental health issues. This type of research involves unique ethical considerations, such as informed consent for individuals with cognitive impairments or the balancing of autonomy and protection in decision-making. Ethical review and oversight are crucial steps when conducting research, ensuring that studies involving people adhere to ethical standards and principles^[v], thus protecting the rights, dignity and safety of those involved. Depending on the nature of the project and the level of risk, additional burden or intrusion, approval of a research ethics committee is required (e.g. NHS REC, University REC).

Ethical review: “An ethics review must be proportionate to the potential risk or harm that the research imposes. Risks should be balanced against benefits and, where possible, risks should be minimised. Ethical considerations are different where there is minimal risk of serious harm, and moderate risk of minimal harm. These considerations apply whether the research involves primary use as well as the re-use of data.” Source: Our expectations of ethics review – UKRI Research Ethics Committees (RECs): “Research ethics committees aim to protect people who take part in research. This helps promote public confidence about the conduct of researchers and the dignity, rights, safety and well-being of research participants. As a result, more people will be encouraged to take part in research. This in turn leads to more, better and quicker improvements in health and social care.” Source: GAfREC, page 3

Challenges with the current landscape in Scotland

In Scotland, the ethical approval processes for research involving recipients and providers of social care are often unclear and complex (see also Annex 2). Some social care research is required to undergo review by an NHS or a university research ethics committee. For other types of social care research, there is no route for independent ethical review. Unlike in other parts of the UK, there are also no Research Ethics Committees (RECs) flagged to review social care research in Scotland. In some cases, the lack of infrastructure and support means that planned research will not take place in Scotland, to the detriment of users of social care, the social care sector, and the research and innovation sector^[49].

With regards to innovation, the GEARED UP project states “there are no specific or dedicated processes or routes for those wanting to repurpose data for innovation or use data on care home residents specifically……. The use of both health and social care data for innovation by commercial companies is also acknowledged as less than straightforward and in need of improvement to ensure that innovation is well supported and inclusive, with sound and secure oversight^[50].”

During the stakeholder engagement and evidence gathering phase of the care home data review, it was highlighted that there are numerous challenges with accessing social care data for research and innovation. The recently published GEARED UP project report also outlines the governance, ethical and practical issues with using care home data for research, service evaluations and Innovation Challenges/Test Bed work. Challenges include:

• Inconsistencies in accessing social care data, and a complex and time consuming process.
• Some social care research projects have no immediate source of ethical review by an independent committee due to the lack of infrastructure and support for non-NHS studies.
• Lack of social care expertise in existing ethical review committees.
• In England there are 3 RECs that are flagged to review social care research in addition to health care research. These three RECs are capable of reviewing social care research studies from England, Wales and Northern Ireland. Moreover, both Health and Social Care (HSC) RECs based in Northern Ireland can also review Northern Irish social care research studies. There are no RECs flagged to review social care research in Scotland.

The report also suggests that guidance and signposting be improved to direct social care projects towards particular Ethics Reviewing bodies (RECs, ESRC (Economic and Social Research Council), Local Authorities etc).

Improving our care home evidence is critical to shaping policy and practice in care homes, thus ultimately leading to improvements in care. There are also economic benefits with “more money and jobs if the UK environment for research attracts international research funders to invest and carry out their research here^[51]”. The current ethics infrastructure to support research and innovation is complex, time consuming, and inconsistent. This is to the detriment of improving care. A number of actions (see Recommendations) have been identified to address the challenges around the current ethics infrastructure. To take forward this considerable programme of work, a Social Care Research Ethics Working Group will need to be established. This working group should include representation from a range of national and local organisations (e.g. local authorities), NHS REC, academia, care homes, and residents / families to ensure any future research ethics guidance and infrastructure reflect the needs of the care home sector (and the wider social care and social work sector).

The programme of work should consider the recent review of Clinical Trials Regulations. Furthermore, the programme of work should also build on the work of the GEARED UP project to understand the current ethical review landscape in Scotland before ultimately producing a social care data ethics guidance for Scotland which should establish a clear route for social care research and innovation projects. In addition, the Social Care Research Ethics Working Group will be tasked with outlining options to address current infrastructure gaps. Any proposed new processes by the working group, should where possible, align with social care research / innovation information governance applications to ensure efficiency. The new processes should also clarify when a project will need ethical review and when Information Governance is sufficient in managing risk. Much of the above work programme will take longer than a year to develop and put in place. However, there are some medium term solutions which can be put in place whilst the social care research ethics guidance is being developed, for example, consider social care representation on RECs (and PBPP (Public Benefit and Privacy Panel), see Data Sharing chapter for further information) who are reviewing social care research and innovation projects, and improving the sign posting through the current landscape.

Case study: ENRICH Scotland

ENRICH Scotland (Enabling Research In Care Homes) has been funded by CSO (Chief Scientist Office) since 2021. It brings together care home staff, residents and researchers to facilitate the design and delivery of research, to improve the quality of life, treatments and care for all residents. It aims to be a ‘one shop stop’ for research in care homes in Scotland and includes an active PPI (Patient and Public Involvement) group called RICH Voices who can input into the design, delivery and interpretation of studies, and now has around 400 care homes signed up as ‘Research Ready’. Enquiries from researchers, including undergraduate and postgraduate students, has highlighted the lack of understanding of ethical processes, and the lack of clarity on how best to proceed for different study designs.

Ethics: Aims and recommendations

Aims: To embed an ethical based approach to the use of care home data in Scotland which maintains public trust and confidence.

Recommendations: Scottish Government (SG) to establish a social care research ethics working group comprising representation from a range of national and local organisations, care homes, residents and other social care service users to take forward the following:

i. Building on the GEARED UP project, map the current ethical review routes for using social care data / undertaking social care research to identify gaps and inconsistencies.

ii. Produce recommendations for addressing gaps in the social care research ethics infrastructure in Scotland.

iii. Consider how social care can be represented on Research Ethics Committees (RECs) / PBPP who are reviewing social care research and innovation projects.

iv. Create and publish guidance on applying social care research ethics in Scotland to support the review process for social care research and innovation by establishing a clear pathway for accessing and seeking ethical and governance approval for using care home and other social care data.

v. Align (where possible) with social care research / innovation information governance applications with the aim of achieving an efficient approvals process.

Chief Scientists Office and Digital Health & Care Division (SG) to ensure the social care research ethics programme of work is aligned to any planned SG Health & Social Care wide ethics work and SG wide ethics work.