NHS patient data – research resource or ethics minefield?

There has been an interesting development in relation to research data this week, specifically health data, which potentially has far-reaching implications for research ethics.  Addressing the inaugural meeting of the Global Health Policy Summit in London on 1st August, the Prime Minister stated that the government is carrying out a consultation on changing the NHS constitution ‘so that the default setting is for patients’ data to be used for research unless the patient opts out’.  The intention is to harness ‘the incredible data’ held in the NHS, to make the UK a world leader in making anonymised health service data available to researchers, and therefore make the UK ‘the best place in the world to carry out cutting edge research’.

This development could have significant benefits for research and for future healthcare, but seems likely to raise  significant challenges regarding the management of data, data protection and research ethics, issues that already exercise the research community.   The Information Commissioner’s Office has fined healthcare trusts in London and Wales in recent months for breaching data protection rules, for example.  More fundamentally, it will be very interesting to see how this proposed change in policy might address an issue such as informed consent when the default is to be opted-in to consent.  This seems especially problematic given that David Cameron explicitly referred in his speech to ‘long-neglected areas like dementia where the burden of the disease is immense but the obstacles to prevention and cure are equally large’.  Considering the legislative and practical complexities involved already when  establishing consent with such patients, it seems reasonable to assume that this consultation will find research ethics is one of the major obstacle it faces.