The report, eagerly anticipated by researchers, medical research charities, the pharmaceutical industry and Government, provides – for the first time ever – an overview of the current regulation and governance of health research.
It also puts forward recommendations to overhaul processes and provide an environment in the UK that will enable more health research to happen, whilst continuing to protect patients.
As we await the Government response to this report, we thought we’d outline what the review recommends, and what we think about it.
Why was the review needed?
Properly regulated health research protects the public against untested medicines and other technologies, and provides oversight of researchers’ conduct, in both academia and the public sector.
However, the way health research is currently regulated in the UK is complicated, and so researchers have to jump a multitude of bureaucratic hurdles when trying to set up new studies. Many in the research community feel these hurdles do nothing to actually improve safety for people involved in the research.
To investigate this, in March 2010 the Department of Health asked the Academy of Medical Sciences to review the way health research in the UK is regulated and governed, and to work out how to enhance and streamline the current pathway, while ensuring the protection of participants.
To do this, the Academy asked people and organisations involved or interested in heath research to submit evidence and opinions. They ended up receiving more than 300 submissions from a wide range of stakeholders – the most that the Academy has ever received for such an exercise.
Looking at all the evidence, the Academy concluded that the biggest barrier to setting up research studies was the process that NHS Trusts currently use to approve such studies.
Who conducted the review?
The working group that carried out the review was chaired by Professor Sir Michael Rawlins – the current chairman of UK drugs regulator NICE. Cancer Research UK’s chief clinician, Professor Peter Johnson was a member of the working group (although both were acting independently and in a personal capacity). Other members included representatives from Industry, the NHS, the public, and legal and ethical experts.
Given the number of people involved, and their diverse backgrounds, there was a remarkable degree of agreement about what needed to be done.
What does the review recommend?
The report’s main recommendation is that the government establishes a new independent Health Research Agency, to coordinate the way health research is regulated and governed. The proposed body would have two major functions:
- to rapidly approve NHS research proposals via a new National Research Governance Service
- to unify the system for ethical approvals
The Academy also recommends changes to the European Clinical Trials Directive; the way patient data is used in research; and to the culture in the NHS, to better embed research in the way it works.
The report has already been backed by a number of key stakeholders in health research: the Wellcome Trust; the Medical Research Council and Association of British Pharmaceutical Industries.
What does Cancer Research UK think?
We also fully support the review’s recommendations. Health research studies in the NHS are vital in cancer research, whether they’re population studies that require use of patient data, or clinical trials of treatments or screening.
The NHS treats the largest group of people in a single healthcare system in the world, and keeps detailed records on all patients from birth to death. With an ageing population and the need for the NHS to become even better and more efficient, the UK Governments need to provide a supportive environment for health research studies within the NHS.
But under the current system, cancer patients are missing out on taking part in studies, because of the unnecessarily complex and bureaucratic processes that researchers have to navigate to set up their studies. So we’re fully behind the report and its recommendations, and believe that a single Health Research Agency could significantly improve the current system.
To discuss the review, our director of clinical research, Kate Law, appeared alongside Professor Rawlins on BBC Radio 4’s Material World programme on Thursday – you can listen on iPlayer here.
How have others reacted to the review?
On publication of the report the Secretary of State for Health, Andrew Lansley, issued a statement that said:
National regulation and local governance of health research are too complex and scattered across too many different bodies. The Academy’s report makes the case for simplification under a health research agency that will streamline and co-ordinate regulatory and governance processes. The Government welcomes the report and will consider carefully how to implement its recommendations.’
It prefers careful surgery to the slapdash ‘slash and burn’ approach beloved of short-sighted politicians when talking about regulation or quangos. Its prescription for the future is measured and precise – there are no sledgehammers to crack nuts here. It takes a wide-lens view of the issues, not least the extent to which the NHS has largely been allowed to brush-aside its role in research. And lastly, for an Academy report, there is a refreshing recognition of the importance of public and patient involvement.
And Sir John Savill, Chief Executive of the Medical Research Council (MRC), told the media:
It is essential that the regulatory system for clinical research in the UK is simplified and made more risk-proportionate. The MRC considers that the recommendations identified by the AMS are a pragmatic way forward, and would be happy to work with Government and others to put them into effect.
It’s great to see such a unified, enthusiastic response to this report. It’s now up to the government to take forward these recommendations without delay, and make it easier for cancer patients and the public to benefit from the world-class research that takes place in this country.
Emma Greenwood is a policy researcher at Cancer Research UK, and was seconded to the Academy of Medical Sciences to work on the review.