Patients, ethics committees and clinical research – NRES/INVOLVE report highlights ‘public’ challenge for new health research regulator (HRA)

Sometimes you are just defeated by the brilliance of others.  So, if you are looking for a wonderful summary of what the autumn statement means for health research, then I can highly recommend Becky’s Policy Pages.

Clearly, the opening up of health data is the single most important strategic announcement in today’s statement – much more so than the windfalls of cash for various parts of science.  We’ll learn more next week, and more in the months ahead, and no doubt I won’t be able to resist saying something on the matter.

But something else dropped into my email this morning which I wanted to share.  It is highly relevant to the unfolding changes in the landscape for medical research and, in particular, the impending establishment of the Health Research Authority (HRA). 

Further details about the HRA will be announced on 1st December.  But we do know this.  The HRA will be the regulator for health research and, effectively, the new kid on the block.  It is likely to take some considerable time to see the full body up-and-running but, in its first iteration, it will encompass the functions currently performed by the National Research Ethics Service (NRES). We are talking evolution here rather than revolution.

From a public and patient point of view the fact that NRES will be at the core of HRA is significant in a number of ways.  The email I referred too earlier was announcing the publication of a joint report by INVOLVE and NRES entitled ‘Public involvement in research applications to the National Research Ethics Service.’ 

The report is based on scrutiny of a sample of applications to NRES with the aim of seeing how researchers responded to questions on the application form about how they intended to involve the public in their work.  Remember, all research applications have to go to ethics committees and get their approval before a study or trial can go ahead;  these committees include members of the public among their number. 

In shorthand the report shows that just less than 1/5th of researchers responded with plans to involve the public, 43% of researchers seemed to misunderstand what they were being asked and 38% said they had no plans for public involvement.  There is quite a lot of variation between different types of research as defined by who the funder is – NIHR funded research performing well, charity funded research applications being average, and industry seemingly having no knowledge that there is a public out there at all!

The report is a snapshot of the challenge we still face in getting a public involvement component included in research – and this despite the mounting evidence of its benefits.  But at least we have some frontline data against which to track future progress.  The upshot based on this evidence is that funders need to get their act together in challenging rearchers to demonstrate how they will involve the public, ethics committees need to step up in asking more searching questions of researchers, and NRES also has a clear role in asking sharper questions of those applying.

From 1st December this challenge will increasingly be a matter for the HRA to own.  But NRES, as the first tenant of the new regulator, has a more important role than most in ensuring its landlord meets this challenge and is seen to act ‘in the public interest from day one.’   NRES has a leadership that is committed to the public involvement agenda, it has an established network of committee where public involvement is active and now it has the evidence in this report to back it up.

What’s that saying?  Some are born great, some become great and some have greatness thrust upon them.




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