18 February 2015
A new report from the Nuffield Council on Bioethics says that failure to engage effectively with the public risks undermining the potential value of biomedical data projects.
Biomedical and technological developments have created a rapidly increasing volume of biological and health data. Combined with new methods of analysing biomedical big data of this kind, the potential for both valuable research and improved healthcare is enormous. There is therefore understandable enthusiasm for initiatives to store, share and interrogate data. Recent examples focus on genomic data, such as the 100,000 Genomes Project and Scottish Genomes Partnership, but these in turn build on links with electronic clinical information. Health records databases have themselves been the focus of focused initiatives such as the the Scottish Informatics Programme (SHIP) and the more contentious NHS England care.data programme.
However, the new Nuffield Council report, The collection, linking and use of data in biomedical research and health care: ethical issues, says that public participation must be a central element of big data projects of this kind. This recommendation has an ethical, but also a highly practical basis; the Working Party behind the report warned that failure to take public preferences and values into account could undermine public trust and ultimately limit both participation and the resulting value of data projects.
The report notes that the potential value includes the capacity to improve healthcare by generating a robust biomedical evidence base for better and more personalised approaches to disease prevention, diagnosis and treatment. There is also scope to create new efficiencies in health service delivery and underpin biomedical innovation and economic growth - aims dear to the UK government, as set out in the 2012 NHS Innovation, health and wealth report.
However, risks include loss of privacy and security; impaired medical care where data is not appropriately shared; discrimination and other forms of data misuse. For example, there have been reports that the care.data programme failed to act on patient requests to opt-out due to concerns that their health records could be used by insurers or other companies.
The report notes that many potential harms of this kind are both under-reported and inadequately addressed by current legal or regulatory measures. It therefore calls for more research into the misuse of health data and UK safeguards including the introduction of robust criminal penalties for the deliberate misuse of data ‘whether or not it results in demonstrable harm to individuals’.
Finally, the report also calls for improved governance of biomedical data initiatives, including transparency about how people's data are used, clear explanation of the limits of privacy, disclosure of privacy breaches, ongoing active protection of the rights and interests of participants and accountability for failures to do so, concluding that:
'To marginalise individuals who provide data means risking the trust of current and future generations, exposing people to unacceptable risks, and ultimately missing out on the benefits of research.’
Professor Martin Richards of the University of Cambridge, who chaired the Nuffield Council on Bioethics Working Party behind the report, said: "There is a strong public interest in the responsible use of data to generate knowledge, drive innovation and improve health. However, people understandably have concerns about their privacy. If we don't get this right, we risk losing public trust in research, and ultimately missing out on the benefits this t ype of research can bring".