The collection, linking and use of data in biomedical research and health care: ethical issues

There are a number of examples of data initiatives at different levels within the UK National Health Service (NHS). Initially focused on improving business efficiency and the delivery of care, data initiatives within the NHS increasingly aim to support biomedical research and public policy objectives.

The report suggests that without adequate public consultation and involvement, along with trustworthy governance systems, which respect the interests of those involved, initiatives that could have wide public benefits may continue to be challenged and fail to secure public confidence.

Appropriate use of data

NHS England’s care.data initiative aimed to upload all GP-held data to a central repository, the Health and Social Care Information Centre (HSCIC), for research and other health-related purposes. Individuals would be able to opt out of having their data uploaded.

The reaction of GPs, civil society and the media demonstrated that the uses intended by the HSCIC, while provided for in law, were not consistent with people’s expectations about how their data would be used, including by companies outside the NHS.

The programme was postponed in order to create the opportunity to establish more appropriate governance measures. In addition to the involvement of the HRA Confidentiality Advisory Group and the appointment of a National Data Guardian, broader public engagement could help to address questions about what uses of data are ethically appropriate so that, for example, patients can properly consider what the implications of opting out mean for themselves and the public interest more broadly.

Commitment to public engagement

An alternative approach was taken by the Scottish Informatics Programme (SHIP). A key feature of SHIP was its commitment to public engagement – both in determining the acceptability of the initiative, and as an integral part of its continuing governance.

SHIP demonstrates a number of elements of good practice according to our ethical principles. Risks and benefits are assessed on a case-by-case basis, focusing on context rather than simply the type of data used. The initiative aims to respect public and private interests, partly through public engagement; and it takes seriously the need for public trust and concerns about the involvement of commercial interests. Through its system of research authorisation it also acknowledges the importance of responsible behaviour on the part of professionals over and above the duty to respect the consent of patients, even where data with a low risk of re-identification are used.

Public-private collaboration

A third example is the 100K Genomes project, delivered by Genomics England Ltd, a company owned by the UK Government. The project was established with strong political backing, to use the NHS as a resource to realise the prospects of genomic medicine.

The project is clear about generating economic returns but, given the private-public relationship, there is a need for a clearer public account, and greater public accountability, regarding how its governance serves the public interest.

We conclude

The report makes a number of recommendations in relation to data initiatives in health systems, including that, for HSCIC:

• An independent, broadly representative group of participants should be convened to develop a public statement about how data held by the HSCIC should be used.
• There should be complete audit trails of everyone who has been given access to the data, and the purposes to which they have been put. These should be made available to all individuals to whom the data relate or relevant authorities in a timely fashion on request. [Chapter 6]