Back in February, the Academy of Medical Sciences, Cancer Research UK and the Wellcome Trust invited lots of clever people involved in health research into a room to discuss work underway to improve the way health research is regulated and governed in the UK. Today they’ve published a great summary of the discussion which pulls together the detail that was discussed and looks forward to how the whole research community can work with the government to really make this work for research. And at 9 pages long, it’s a brilliant quick and easy to understand summary of where we’re at. And if you want an even shorter summary – check out Cancer Research UK’s blog.
There is lots of work afoot to streamline the regulation and governance of health research in the UK – to make sure it does its job well to ensure we have high quality, well-regulated research but doesn’t put unnecessary barriers in the way of good projects going ahead.
This includes plans to set up a single regulator of health research – the Health Research Authority – which is up and running as a special health authority at the moment. The Queen’s speech just last week announced that the government is planning to publish draft legislation to establish this as a non-departmental public body this year.
The EU Directive on clinical trials is also in the process of being revised in Europe. The current directive dates back to 2001, but since its introduction there have been difficulties in implementing the regulations and concerns that they may actually be leading to unnecessary delays and escalating costs. The European Commission held a consultation on how to update the directive in the first half of 2011 and we are expecting proposals later this year on how they plan to update the directive. This will then need to be debated by the European Parliament before it can be adopted across Europe.
The governance of health research in the NHS is also being overhauled. One well-recognised barrier to setting up research studies is the process of seeking research & development permissions from NHS organisations. Permissions are often needed from multiple organisations if projects are taking place across several sites. The government published a plan for growth back in March 2011 which set out to streamline the process of obtaining NHS R&D permissions. This introduced a 70 day benchmark for the first patient to be recruited to a trial. NIHR funding will become contingent on NHS organisations reaching these benchmarks so there are big incentives for them to streamline their processes.
There is a new duty to promote research on the Secretary of State, the NHS Commissioning Board and Clinical Commissioning Groups that was introduced by the Health & Social Care Act 2012 and as these new bodies get up and running, work is underway to scope out what these duties will look like in practice and how these can contribute to a culture of research in the NHS.
Patient records are a rich source of data for health research and lots of initiatives are underway to explore how we can improve safe and secure access to this data for research. The newly established Clinical Practice Research Datalink aims to support the sharing of this information safely and securely. A new NHS Information Strategy is expected imminently and an independent review of the balance between protecting patient information and its sharing to improve patient care is underway – the Caldicott review. The government is also planning a consultation later this year about changes to the NHS constitution, asking NHS users if they want researchers to be able to access their health records unless they expressly choose to opt out.
What came out of February’s discussion?
Health Research Authority - Welcomed the speed with which it has been established as a special health authority and emphasised the need for it to work with the research community, patients and the public as it gets up and running and consider the functions it should take on to really create a streamlined and effective regulatory process for research.
Clinical trials - Welcomed the work the MHRA has done in the UK to streamline the process within the current european regulatory framework. Agreed that the UK research community should work together to engage with the revision of the clinical trials directive in Europe to push for the changes we want to see to allow a more proportionate approach to regulating clinical research.
Changes to NHS research governance - There is a lot of work underway to streamline NHS R&D permissions but there was a concern that there needed to be more coordination with other steps in the regulatory pathway to ensure this is effective.
Patient data - There was agreement that we need to get the framework and regulatory system right and that patients, the public and healthcare professionals need to be involved throughout the process as develop this. We also need to engage with the revision of the EU Data Protection Regulation which is happening now and will impact on the management of patient data in the UK – we have supported a joint statement outlining some of the issues with the proposed regulation.
The report concludes with a plan of action. Everyone involved in research needs to work together and listen to each other to get this right – the solution will involve all of us. That includes patients and the public who should have a say throughout the process of design and regulation of research. Everyone at all levels should champion research. And we need to monitor all this change and feedback to make sure we are getting it right and tackle it where we aren’t