An ethical approach to using care home data

2. Current landscape in Scotland

The 2023 report from the ‘GEARED UP project^[4]’ (The Care Home Data: Governance, Ethics, Access and Readiness Demonstration) outlines the current infrastructure in Scotland for the ethical review of care home research and innovation projects. A relevant modified extract can be found below:

2.1 Ethical infrastructure for research and innovation

The Health Research Authority (HRA), in partnership with the Devolved Administrations, provide a UK-wide Research Ethics Service to ensure that the research conducted in the NHS in safe and ethical. This Research Ethics Service consists of NHS Research Ethics Committees (RECs), in addition to head offices that manage the operations of such Committees. NHS RECs review studies to determine if they are being delivered in a fair, ethical and appropriate way. They are governed by the Governance Arrangements for Research Ethics Committees (GAfREC). Under GAfREC, NHS RECs are required to follow standard operating procedures.

The UK Policy Framework for Health & Social Care Research^[5] sets out principles of good practice and conduct in the area of health and social care research that falls within the remit of the HRA or Devolved Administrations' Health Departments. In Scotland, this Framework applies to health research and adult social care research. This can include care homes.

A directory on HRA website gives details on all NHS RECs in the UK.

All applications to NHS RECs are made via an online system, the Integrated Research Application Service (IRAS). IRAS is a single system for applying for the permissions and approvals for health and social care / community care research in the UK.

For social care research carried out by universities: If the study does not fall within the scope of the Adults with Incapacity (Scotland) Act 2000, or does not involve NHS patients, data or staff, the investigator should seek a review from their university REC.

For research carried out with local authorities / local authority supported social care clients / local authority supported care home residents, then local authorities should have their own procedures in place. The recommendations from the Care home Data Review include further mapping of the current ethical review routes for using social care data / undertaking social care research to identify gaps and inconsistencies. This includes understanding processes in each Scottish local authority.

Social care research does not require review by a REC within the UK Health Departments’ Research Ethics Service if it is reviewed by another committee operating in accordance with the Economic and Social Research Council’s Framework for Research Ethics^{[6], [7]}, (for example, a University REC) unless any of the following apply:

In Scotland, GAfREC does not normally require NHS REC review of research in social care settings. This would only be required in instances where:

• The study falls within the scope of section 51 of the Adults with Incapacity (Scotland) Act 2000. E.g. it is surgical, medical, nursing, dental or psychological research proposed to involve adults who lack the capacity to consent for themselves as participants.
• The study involves NHS patients (identified through their use of services), or a mix of NHS patients and social care users (identified through their use of services).

However, NHS RECs in Scotland will generally accept voluntary applications for review of social care research which is related to healthcare.

Some social care research – for example, research carried out by researchers not employed / carried out by local authorities or universities – has no immediate source of review by committee (in Scotland).

Research projects using the National Safe Haven (NSH) may be covered by the NSH’s existing ethical approval for secondary analysis of PHS (Public Health Scotland) data. The electronic Data Research and Innovation Service (eDRIS) is able to facilitate research that meet the criteria below because PHS has sought and achieved a favourable ethical opinion from the East of Scotland NHS Research Ethics Service.

To meet the conditions, the research study should:

1. be in the field of health or social care research;
2. not involve any contact with research participants/subjects;
3. have undergone scientific peer review;
4. include data held in and accessed via the national safe haven;
5. be carried out by UK based researchers only

eDRIS are required to submit an annual report to the NHS Research Ethics Service that documents all of the studies that have been undertaken using national level, de-identified data for health and social care research.

In addition to the National Safe Haven there are 4 regional safe havens. These operate in the regional hubs of Aberdeen, Dundee, Edinburgh and Glasgow.

The regional safe havens have their own procedures in place for social care research carried out in them. The recommendations from the Care home Data Review include further mapping of the current ethical review routes for using social care data to identify gaps and inconsistencies. This includes understanding processes in each regional safe haven.

Some social care social research may not meet the UK Policy Framework for health and social care research definition of research, however there is other guidance for ethical review which should be followed for example, the Government Social Research Ethics Guidance, Ethics for social research: guidance (Scottish Government), and the Social Research Association Research Ethics Guidance.

2.2 Ethical infrastructure for statistics

The National Statistician’s Data Ethics Advisory Committee (NSDEC) has been established to advise the UK National Statistician that the access, use and sharing of public data, for research and statistical purposes, is ethical and for the public good. NSDEC will consider project and policy proposals, which make use of innovative and novel data from the Office for National Statistics (ONS), the Government Statistical Service (GSS) and beyond, and advise the UK National Statistician on the ethical appropriateness of these^[8].

2.3 Role of ethical review in other uses of data

Projects which are not defined as research, innovation or statistics, for example, audit or service evaluations may only require to be (self) assessed against the Health & Social Care Data Strategy Ethical Approach, and in the case of public sector organisations, the Data Ethics Framework. It is however, unclear what, if any, additional local ethical review procedures exist for social care data and analysis in Scotland.