What are the circumstances under which it is acceptable to use confidential patient and service user information without consent for purposes beyond direct patient care?
This is the core question that the 25 members of the Health Research Authority’s Confidentiality Advisory Group (CAG) grapple with at each of their monthly meetings.
It was also the theme of two workshops held in February in London where members of the public and other stakeholders met CAG members and found out more about their work. The event provided an opportunity to inform and influence CAG members’ thinking and help shape an understanding of the issues around dissemination of patient information.
CAG provides recommendations to the HRA and the Secretary of State for Health on instances where essential activities of the NHS, and important medical research, requires the use of identifiable patient information where it is not always practical to obtain consent.
Recent examples of researchers wanting to access data include a study on which children are more likely to develop further complications if they get flu or a flu-like illness, to looking at how clinical practice has changed since the introduction of a new NICE guideline on pregnancy.
The group is made up of volunteers chaired by Dr Mark Taylor, a senior lecturer in the school of law at Sheffield University and deputy director of the Sheffield Institute of Biotechnology, Law and Ethics. CAG’s membership encompasses a broad range of both professional and lay perspectives, in much the same way as a Research Ethics Committee does.
Dr Taylor said:
“It is a central aim of CAG to support uses of identifiable patient and service user data under conditions people accept as appropriate. Our understanding of what is acceptable needs to be continuously challenged because it is in all of our interests that it is robust.
“Events such as this one are an essential part of ensuring that the decisions we make as a group are reflecting the views of society more broadly.”
Members of the public attended the workshop for a variety of reasons. For some it was a general interest in how CAG’s decision-making fitted into the broader research environment; for others personal experience of having their data used had sparked an interest in how data is linked in the health and social care system.
Participants were given an introductory presentation by CAG member Clare Sanderson, and were then posed a series of questions exploring the different aspects of CAG’s decision-making process, including, for example, what considerations CAG should take into account where the disclosure of NHS patient data for medical purposes could bring about a clear public benefit but also where commercial interests may come into play.
Issues raised in the workshops included the difference between public and private organisations requesting data, and the quality and accuracy of the data used. Participants were clear that more information about the benefits of using data in this way would be helpful, and explored the importance of defining what ‘public benefit’ is and who it is that decides.
Retired surgeon and medical director Patrick Coyle, one of the CAG members at the meeting, said:
"This event is very important. We expect our applicants to have consulted public and patients at all stages of development of their projects so we should equally consult on our activities.
“Our primary purpose is to ensure that applicants comply with the framework of law governing the use of identifiable data but it is also essential that the public remain confident that their data is properly looked after. Our best way of testing that public confidence is through events such as this.
“It was very helpful to hear the strong view that members of the public feel that, wherever possible, consent remains the preferred legal basis for the use of data.”
“Seeing these discussions evolve over the course of the workshops was extremely valuable,” said Dr Taylor, CAG Chair. “This information will feed directly back into the frameworks we are developing to aid our considerations as a group.”