It will be the single most important and transformative development in medical research this year. It will change the relationship that patients have with their health service and fundamentally re-draw the relationship between the NHS and its partners including our healthcare industries. It’s impact on the culture of the NHS and the way it is run, will be deeper and more long-lasting than the entirety of the reforms contained in the Health and Social Care Bill.
I am not talking about a specific scientific discovery but the Government’s clutch of proposals to open-up access to medical records: to patients; to researchers and; to a range of public and private organisations. The initiatives were announced in the final weeks of 2011 and I expect this year we will see us move quickly through the process of consultation, refinement and initial implementation of policy.
Tim Berners-Lee, Director of the World Wide Web Consortium and Director Designate of the Open Data Institute, and Professor Nigel Shalbolt, Head of the Web and Internet Science Group at the University of Southampton and Director Designate of the Open Data Institute, wrote in The Times (paywall) on New Year’s Eve that ‘data is the new raw material of the 21st Century.’
That assertion is more true of the NHS than any other organisation in the UK. Data is the least toxic and most promising commodity at its disposal and it would seem that Ministers and NHS leaders are at last waking up to its potential. It is also the basis of the arguments that the medical research community – including many charities and patient groups - has made for easier and better access to patient data for research purposes. The aim: to create ‘new opportunities and [make] the UK a world leader [in research]‘ – to paraphrase another statement in the aforesaid Times article. I think most of us would buy into this future goal.
The focus of the debate this year will be about getting right the future rules for the trading and sharing of this new commodity in the system - from the perspective of the individual patient in how they access and use their data and from the perspective of the NHS – and others for that matter - in terms of the insights they can take, and use they can make, from its analysis and aggregation.
Already when it comes to the use of patient data for research purposes, much comment has focused on the need for patient confidentiality to be the ‘first among equals’ of these new rules for data sharing and trading in the NHS. In their article, Berners-Lee and Shadbolt also focus on the need to respect individual privacy in the new Information Age and highlight the need for a proper public debate on what this means in all areas of life, not just health.
But we should not let this very important element of the new rules obscure our view of the opportunity to discuss much more widely what patients should now expect from medical researchers in return for the right to access to their data; a set of rules that respect the fact that patients should have an increasing say in how research is conducted, a set of fundamental rights which acknowledge their increasing role as co-innovators.
Such rights might include the following:
- The right to better access and information about clinical trials and clinical research, available both at the point of sale in the GP surgery but also through tools such as the UK Clinicial Trials Gateway. Almost all the feedback that I have received from colleagues about the latter is that, while welcome, it has yet to really provide information in a way which is easy to understand for its primary audience – patients – through lay summaries on each of the individual projects.
- The right to involvement in how UK medical and health research is governed by the new health research regulator, the Health Research Authority(HRA). To this end I am pleased that HRA even in its infancy is setting up an advisory group involving AMRC, INVOLVE and others to inquire more deeply into how this might be achieved.
- The right to expect that all funders who are funding clinical research within the NHS system, have involved the public in the design and conduct of that research. The report by INVOLVE and the National Research Ethics Service (NRES) published just before Christmas and which showed that only applications received from NIHR funded researchers by and large pass muster on public involvement, is a wake-up call to us all on how far we still have to go on this front.
- The right as a patient involved in a trial or study to expect certain ‘contractual’ obligations to be met by researchers such as proper feedback and follow-up with them after a trial has concluded. What did the study show? How has it helped? How has their involvement helped?
- The right to open and free access to the results of trials and studies as published in journals and an end to the current distortion in publicly available information caused particularly by the tendency of pharmaceutical companies to prefer to publish positive as opposed to negative results from studies – and I am putting that kindly and mildly.
After all, doesn’t one good right deserve another?