I am prone to beating up our Royal Colleges for one reason or another.  But, over the last few years, I have grown to admire and respect the work of one of their number in particular – the Royal College of Paediatrics and Child Health (RCPCH).

Yesterday, RCPCH launched a new report entitled ‘Turning the Tide: Harnessing the Power of Child Health Research’ which is part progress report and part agenda for change.  The College’s campaign will aim to:

  • Debunk the myths surrounding clinical trials – and push for the introduction of a system of ‘opting out’ of  studies designed to reduce uncertainties in treatments, rather than ‘opting in’
  • Bring organisations together in a UK “Children’s Research Collaboration” to optimise use of funding for research and raise awareness of the need to strengthen children’s involvement
  • Improve education, research training, and guidance for paediatricians: with the RCPCH pledging to improve research training for all paediatricians  and clear routes into research careers
  • Strengthen the infrastructure for children’s biomedical research in the UK by supporting the establishment of a children’s trials network for non-medicines as well as medicines studies, and children’s health sciences networks to share resources, and promote cross-institutional collaboration between paediatricians, adult physicians, and non-clinical scientists researching the early life origins of adult diseases

There’s a very powerful section in the report about what the NHS should be doing which you could read across many, if not all, other conditions.

Two additional comments.  The idea of a UK Children’s Research Collaboration (UKCRC! funnily enough – see yesterday’s blog) is a good one.  Quite apart from the greater co-ordination of efforts that would result, precedent suggests it will also help amplify the message (one of the points Richard Smith noted in his BMJ blog today about charities needing to work together more).  The arguments in favour are given further force this afternoon by the news that donations to medical research charities are now falling (see AMRC blog).  Quite simply it is about efficiencies of scale.

I’m also delighted that RCPCH and its partners are going ahead with the idea of a ‘children’s charter.’  The College seem to have developed a strong public involvement model of working and I went to one of their meetings with young people and parents a few months ago as part of the ‘Turning the Tide’ preparation work.  This was an idea that came out of that meeting and I am pleased it has gained credence with the report authors including Neena Modi, Vice-President at the College.  In setting out children’s rights and expectations when it comes to research I am sure we would all wish to support and applaud its development.

So there I was yesterday afternoon,  with my biology ‘o’level a distant memory to put it mildly, speaking at the annual NIHR Senior Investigators Meeting thinking: ‘how did I ever get into this?’  The event brings together the very best of NIHR’s  researchers for an update on what’s happening across health research.  And this was mentioned at last night’s dinner and announced this morning.

The new Health Research Authority (HRA) have been given the Department of Health’s go-ahead to do a feasibility study into developing a simplified and streamlined HRA assessment for all research in the NHS.  If I have got this right, that potentially means a move away from the situation we can currently have, where NHS Trusts decide they all ought to do the same assessment before the research can get underway.  You got it, that means lots of duplication, delays, a waste of money and patients losing out.

So this would mean HRA would do the assessment and Trusts would only have to think about their ability to deliver the research, while local research ethics committees could concentrate on new issues it raises.

I’m sure that if I have got that rather crass paraphrasing of the announcement wrong, someone will put me right.

A long way to go but more radical than it sounds.

I noticed this in Civil Society from a few hours ago.  Cancer Research UK (CRUK) – the largest publicly funded medical research charity in the UK – is reported to be launching a new identity in September to coincide with the 10th anniversary of its establishment from the merger of Cancer Research Campaign and the Imperial Cancer Research Fund.  The article includes an extensive interview with CRUK’s director of marketing and fundraising, Richard Taylor, as well as a sneak preview of the new logo.  Rather like the change and the thinking behind it I must say.

Actually that’s not quite true because, as is not uncommon with these things, the evidence session I attended today was more of a discussion, and a very good one it was too.  But I did more or less cover the following points.  At the end we were asked to express one wish about what happens next.  I had a two-part wish:

  • That the NHS Constitution consultation does not become a referendum but is seen as the beginning of a deliberative exercise with the public and patients.
  • That the governance system which emerges enshrines the role of the public as effective co-custodians of good research.

‘Caldicott 2’ speaking notes

 The public and health research

Strong public support for health research – ‘instinctive and altruistic goodwill’ towards it – emotive response not too dissimilar to that which causes people to donate to research charities. Nature of a person’s relationship changes as they begin to have direct contact. Value needs to be better articulated, however, and we need to do a better job of harnessing support.

But low awareness and understanding of how it works generally and, even more so, of particular elements such as use of patient data.  Clearly need to do more to change this but not sure that ‘the fluoridation of water’ population-wide approach to raising awareness will get us very far.  What happens via NHS and Trusts in the context of care much more important – see below.

I suspect people, however, would take issue with the definition of research that some suggest.  Would be an expectation of delivery in terms of treatments, new interventions etc not just advancement of scientific knowledge and understanding.  Real need to de-jargonise information governance debate and try to arrive at consistent definitions and terminology.


Context for people’s individual participation in research is changing.  Now being framed as a ‘choice,’ as an entitlement as part of their care and treatment – NHS Commissioning Board Draft Mandate.  Vision of ‘citizen-driven’ research where people are asserting this right with their doctor.

Changes dynamic.  People will have greater expectations over their rights as well as responsibilities and I am not sure we have thought this through sufficiently within the research community.  It’s no longer a simple exchange or gift relationship. Support is not unconditional.

Strong case for patients and researchers to begin to ‘codify the expectations’ that people can have about their participation and involvement including how their data is used.  Public meetings I have done recently suggests growing frustration over things like consent and the lack of a relationship feel to their interaction. Something I am looking at in my role at NIHR.

Building on the evidence

Have been involved with a number of exercises to gather public opinion an insight into public perspectives on information governance – ‘Your medical records saves lives,’ Academy/AMS report.

Evidence is indicative of public support for sharing data and understanding of benefits but important we don’t overwork or overcook it as if it is a ‘mandate for change’ in itself. It merely gives us license to examine further with them how policy and practice could change.  That is why NHS Constitution consultation so very important.

4 small points about the ‘Your medical records..’ exercise.  First, people assumed their records were being shared anyway. Second, it was a deliberative exercise which enabled people to have their concerns explained away. Third, the biggest barrier to change seemed to be their GP. Fourth, in designing the leaflet people really put a premium on simple, direct information but with clear signposts of where to find out more according to their interests and needs.

NHS Constitution

Welcome the consultation. Need to take a deliberative approach to it. Important to have right mechanisms to hear and understand what people are saying, not just organisations. Also important that we involve the public in the design of the consultation, the framing of its questions and the evaluation of the responses.

Building trust – consent, research governance and public involvement

Three key elements:

Important for people to feel in control of their information and its uses. So, absolutely critical that people are clear about what is being proposed, the pros and cons of opting out, what this means in practice, how data use is going to be monitored etc. In the Facebook era it seems unwise to have a system which does not allow people to choose areas of information they are happy to share, review their decision at appropriate points and re-boot their involvement etc. Or if not, the reason why needs to be clear.

Public involvement in the overall research governance is important to getting the system right from a patient perspective and will help instil trust – patients are effective partners in ensuring good custodianship of research.

Important to have a governance system which is less about transparency and the production of data (as opposed to information) and more about the ability for people to track how decisions were made, by whom and why. Plus what is done if things go wrong.

On my recent visit to Newcastle, my afternoon was spent talking to, and answering questions from, the public about research.  Clinical trials featured heavily.  The most common theme was their frustration over the poor quality information given to trial participants before, during and after a trial had finished.

The journal, PloS ONE, has today published a study by researchers from the University of Southampton (UK),  Harvard Medical School and Northern Arizona University (US) in which they conclude that the information given to trial participants about ‘placebos’ is often incomplete and inaccurate.  In their study they looked at 45 trial leaflets for participants.  They go so far as to suggest that the poor nature of the information provided undermines the principle of ‘informed consent.’  (Medical News Today also cover it here).

Whether it is cock-up or conspiracy that researchers fail to do this I don’t know.  But this sort of stuff really gets to me.  Why isn’t this stuff being picked-up in the trial design at the time of ethics approval? Why does it seem so difficult to get such simple things right?  Why does it need another ‘test’ or ‘trial’ to put it into practice?

The broader issue it points too is the need to codify the rights – and responsibilities! – of trial participants.  I can feel a letter brewing to the HRA.  Hence my headline.