Rawlins Review: Academy lays down law on health research regulation

Over the weekend Professor Colin Blakemore said he hoped the Academy of Medical Sciences would come up with radical proposals to end the regulatory mess that holds up UK health research such as clinical trials.

I am not sure whether he will feel today’s report by the Academy lives up to that aspiration, but I do believe it is a good and important document and I suspect so will my members. Why?

For a number of reasons.  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.  A glint it may only be, but I will take it for starters.

For AMRC member charities who pulled no punches in their commentary on the current system of research regulation and governance, there will be much support for the recommendations to establish a Health Research Agency (HRA) and to house a National Research Governance Service (NRGS) within it which will focus on speeding up NHS R&D permissions.  The fact is that current delays mean it takes far longer than it should to get donor money working for research.  Also, some relief that the review panel resisted calls to collapse the myriad functions of many others regulators into the HRA.  The more one looked at this idea the more it promised a whole lotta pain with little gain.

Its many proposals for improving the culture around health research are not necessarily new – indeed a number of them have long been muted.  But to see them packaged as part of a report which is essentially about better and more efficient delivery of research is extremely important.  It moves us away from considering them as soft components of reform.  They are just as important as cutting red tape and always have been; ministers must now galvanise this culture change with their own backing.

On patient data issues the Academy nudges rather than propels us towards reform. It focuses on specific  levers and measures such as ‘safe havens’ that might get us out of the current fix, while supporting ongoing initiatives such as the Research Capability Programme (RCP) pilots and the North West Exemplar.  Its proposal to make researchers part of the clinical care team would likely have benefits beyond just improving recruitment to clinical trials; it would complement the Academy’s overall call to get the front-end of this debate right by improving NHS staff and public awareness of the importance of patient data to research.  And it almost goes without saying that I am delighted the Academy strongly endorses AMRC’s public awareness work in this field on behalf of, and with, other UKCRC partners.

The fact that the report cites a considerable number of voices from the patient workshop that AMRC and INVOLVE held in November 2010 is helpful to its overall tone and style and it includes the headlines from our independent report of this event without amendment.  It also makes a number of references to the importance of patient and public involvement to the conduct of health research.  But it doesn’t quite give the weight or billing to the need to facilitate greater involvement in the way that I and many others see as integral to improving the UK’s performance in clinical research.

And if there is one further criticism I would make, it is that the Academy keeps a respectable distance from prescribing the leadership make-up and governance systems for the new regulator HRA. It would have been good to have seen it float a few ideas and proposals that further demonstrated that it had taken on board the importance of regulation in ensuring public trust and confidence.

I see that Andrew Lansley has been quick off the mark in welcoming the report.  Watch this space as they say.

Of the coverage I have seen so far I rather liked this one most.

2 thoughts on “Rawlins Review: Academy lays down law on health research regulation

  1. Pingback: Tweets that mention Academy lays down law on health research regulation « Simon Denegri's Blog -- Topsy.com

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