Data collected as part of NHS care can currently be used for approved research. Later this year, the government will consult on whether this should be the default assumption, while protecting the right of an individual to opt out. Donald Nicolson and John Tooke explain their different approaches.
Reuse of patients’ medical data for research already happens and will probably become more commonplace. Public consultation on data reuse is long overdue, and the opportunity for people to decide if their data is reused is welcome. The following problems need to be addressed to enable genuine public engagement to take place.
Problems with opting out
David Cameron has proposed that people’s anonymised data would be used for research unless they opted out.1 But some people may not fully understand what data reuse involves, and many are currently unaware that this occurs.2 Any consultation exercise would therefore need to provide complete and neutral accounts of what data reuse is, its benefits, and the potential risks from accessing and linking data. People’s right to opt out would have to be clearly explained, as well as how they can do so.
The proposal that people opt out rather than opt in might deter some from doing so. Saying that a person’s medical data will be reused unless he or she objects could create an assumption that to opt out is defiant and unhelpful, and so some people might forego this. Because those promoting awareness of data reuse stand to gain from the reuse of data, there is a danger that their informing may actually involve encouraging or ‘nudging’. This might for some be coercive and paternalistic.
Imprecise reasons for data reuse
The reasons given for data reuse are arguably imprecise. Some consider that research is impeded by ethics legislation and that a different research ethics framework would permit more medical research (and breakthroughs). Hence they embrace data reuse to deliver significant advances in medicine. Here the end justifies the means. Yet there is often a lengthy gap between evidence being derived and translated into health benefits. There is no a priori guarantee that data reuse will deliver clear research evidence that can be translated.
A more immediate benefit of data reuse will be to attract industry revenue, important at a time when the pot is getting smaller. Some patients have concerns about industry involvement in research, and so may not be happy if their data were used to attract investment (whether the study delivers important benefits or not). During debates on the NHS Bill earlier this year, there was distaste at the thought of industry profiting from illness. There may be a similar aversion to industry profiting from medical records reuse.
Legislation and individual autonomy
Some argue that the public interest from research findings should outweigh the privacy of individual data. Stated often enough, this may be perceived to be a norm. However, the autonomy of the individual should not be ignored. A person I interviewed about access to medical records said that he perceived there was a push to educate privacy out of people (in relation to medical records). No-one should feel reluctant to claim their right to individual privacy. Yet people in medical records research currently do not have the same rights as people receiving medical care.
Accessing and linking anonymised personal data does not impact on the Data Protection Act (1998), therefore consent is not required and the need to inform people may be considered less necessary, or even completely unnecessary. The European Commission has proposed that data protection rules be reformed; partly to remove unnecessary administrative burdens for processing personal data.3 This will facilitate data reuse more than protect individual autonomy, further shifting the norm to the acceptance of data reuse. Unsolicited data access and the consequences for privacy have been highlighted by the Leveson Enquiry. One hopes that medical research is not becoming arrogant and paternalistic like the press.
1 www.bbc.co.uk/news/uk-16026827  accessed 5 December 2011
2 DJ Nicolson, JC Wyatt, A Salpeter, DJ Willison (2011), Awareness-lite. A review of public awareness about the re-use of their medical records for research purposes. ADEGS/AUDGPI – Annual Scientific Meeting, Dublin
3 European Commission press release (2012). Commission proposes a comprehensive reform of data protection rules to increase users’ control of their data and to cut costs for businesses
Patient data underpins medical research that leads to life-saving new medicines and improves our understanding of diseases such as cancer, dementia and stroke. As a doctor, a scientist and the President of the UK’s national academy of medical sciences, I warmly welcome government plans to meet patient and public health needs by making it easier for their data to be used in health research while retaining current safeguards and the right to opt out. The forthcoming Department of Health consultation on data should provide another opportunity to take forward the recommendations of the Academy’s report, ‘A new pathway for the regulation and governance of health research’.1
Saving lives, developing medicines
Countless lives have been saved through the use of patient data in medical research. Take the link between smoking and lung cancer, for example. It has been estimated that widespread cessation of smoking in the UK between 1950 and 1990 approximately halved the number of deaths from lung cancer that would have occurred had former smokers continued the habit.
Patient data is also vital for developing the next generation of medicines. Current therapies for some diseases take something of a scattergun approach, with all patients being treated in the same way. Better use of patient data can help us identify the right medicines for the right patients, leading to more personalised medicines. This approach has already proved successful in the treatment of breast cancer with herceptin.
Public opinion in favour
Public opinion appears broadly in favour of the use of patient records for health research. A 2009 survey found that nearly three quarters of respondents were willing to allow access to their personal medical records for medical research.2
Another poll in 2011 found a similar proportion would like the chance to take part in clinical trials.3 By supporting the use of their health data patients can continue a virtuous cycle that improves their own health and that of future generations.
Sharing data for collaboration
The NHS holds health records for almost the entire UK population from the cradle to the grave. As one of the largest single healthcare systems in the world, the NHS offers a rich data resource that makes the UK one of the best countries in which to conduct medical science. This international advantage could help UK patients receive newer treatments more quickly as they may have the opportunity to participate in more clinical trials of ground-breaking medicines. Patient data are already used extensively in the NHS to underpin many aspects of routine care and, as such, are frequently shared in a secure and confidential manner.
The commercial sector is the largest funder of medical research in the UK and plays a vital role in translating scientific advances into treatments such as anti-retrovirals for HIV or statins for heart disease. Many of the health challenges of the 21st century are so complex that they can only be tackled through collaboration between patients, healthcare professionals, academics and industry. At the foundation of these alliances lies patient data, crucial for their success.
Access to patient data must be treated with respect. The UK has developed a robust framework to achieve this goal. Patient records cannot be used without review from an independent ethics committee, even if anonymised. Research using identifiable data must also comply with the 1998 Data Protection Act. The provisions to support health research in the recent proposals for the European Data Protection Regulation are welcome, although some aspects of this legislation require further clarification. The Academy’s position on this matter is set out in a recent statement that involved a number of UK medical research organisations.4
With appropriate ethical safeguards patients, doctors, scientists, charities and industry can work together to harness the power of patient data for the public good.
1 Academy of Medical Sciences (2011). A new pathway for the regulation and governance of health research. www.acmedsci.ac.uk/p47prid88.html 
2 Wellcome Trust (2009). Monitor I www.wellcome.ac.uk/About-us/Publications/Reports/Public-engagement/WTX05... 
3 AMRC/Ipsos MORI (2011). Public support for research in the NHS www.ipsos-mori.com/researchpublications/researcharchive/2811/Public-supp... 
4 Academy of Medical Sciences (2012). Joint statement on the European Data Regulation. www.acmedsci.ac.uk/p47prid107.html