health research regulation

This is a really interesting study published in PLOS ONE today.  Eessentially it’s a survey of the attitudes of 2300 participants in TwinsUK (a national biobank) to giving their consent to medical research.  The full paper can be found here.

The results of the survey would seem to highlight what has been a growing theme in the debate about ‘consent’ over many years now: that participants actually have a more flexible and pragmatic attitude to giving their consent than is assumed in the current regulations and regulatory framework.

They certainly want to know the researchers who want (in this case) their data; but they are happy to consent online, and to give an extended warranty for its multiple use over a good period of time.

You could say this is just one study. But the recent Health Research Authority (HRA) public dialogue exercise that I Chaired and which will be published later this year yet again found that the public are remarkably chilled about the things that exercise policy-makers and campaigners most.  Which suggests we probably need to trust our fellow citizens a lot more than we do at the moment.

When I wrote about the latest INVOLVE/NRES study of public involvement in research applications a few weeks ago I was surprised by the response. In the main it was not about which funders were worse at doing public involvement.  No, most people vented their  frustrations about the attitude of ethics committees to proposals for getting consent, public involvement or public engagement in research applications.

They (both researchers and lay people) reported that often these were sent back with a request that they ‘do it again.’ Even though the public have been involved in their design.  And in spite of ethics committees having lay people as members.  Which suggests a certain mindset has taken hold in these local fiefdoms.  A mindet which is not about ‘right touch’ regulation but about ‘always being right’

I know the HRA is on the case of this issue and has indeed been working hard on educating and training ethics committees members.  But iIt’s an area ripe for reform.  In the meantime perhaps ethics committees need to chill out more and, at the very least, stop second-guessing the public in whose interest they are supposed to be acting.

 

The Health Research Authority (HRA) is to be congratulated on its draft guidance to researchers on providing information to participants at the end of the study.  The guidance is open for consultation until the end of this month.

It takes a common-sense approach to sharing trial results with study participants. I challenge any researcher not to find a way of giving people access to study results if they so wish, after reading the document. 

Two paragraphs in the document struck me as particularly refreshing.  The first concerns thanking people for their contribution and states:

‘You should take the opportunity to thank participants for their time and interest and acknowledge the contribution that they have made to research and the improvement of healthcare. It is important that all research participants feel valued and that their contribution has made a difference. This may seem obvious but it is frequently neglected.’

The second encourages researchers to consider asking research participants to become more involved in research after a study finishes.  It says:

Invitation to take part in patient involvement

‘There is an increasing requirement to involve patients and public in the design and conduct of health research. Well-structured involvement can lead to more robust study designs with improved recruitment and lower dropout rates. One way of recruiting people to take part in this type of activity is to invite participants as they coming to the end of study to join a patient involvement group to help provide advice on future studies.

Participation in a health research study may have sparked an interest in research and this information sheet offers an opportunity for such patients to be invited to continue their involvement.’

I mean, ‘Praise the Lord.’  At last a research organisation that has cottoned onto the fact that participation might be a route to a more meaningful and productive partnership.

 

 

 

It being half-term you can never have enough travel games on hand.

Current favourites for me are: a) guessing who will be the new Director of the Wellcome Trust and; b) thinking of  a name for the body  created if you merged all the current Research Councils into one.

I did apply for the former post since you are asking.  I am very hopeful that my double-whammy pitch of making 75% of the Wellcome Trust Governors members of the public or patients (all of whom will be paid a very reasonable INVOLVE rate of £150 a day), and of building a ‘Crick’ in every town in the UK so that everybody has a ‘Crick in their neck of the woods,’ will get me the job.  In the meantime Ted Bianco (no relation to Matt as far as I know) will be Acting Director from March.

As for that merged body, the leading name is ‘Best Left Alone,’ on the basis that all future Science Ministers with not a clue, will find this a reassuringly named out-tray in which to put offending papers for ‘those experts to deal with.’  Not only that but, given the organisation will be based in Swindon, to most Ministers that’s as good as putting it at the end of an unmarked exit on the M4.  And, at the very worst they can quite quite truthfully report to parliament that all Government funding for the science councils has gone down a BLACK hole.

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If I don’t get to see any of these visions come true then I shall turn my attention again to saving the Royal Institution (RI)  as I did just a few weeks ago.  I see the Chair of the RI Board of Trustees, Sir Richard Sykes, wrote a blog in The Guardian on 8th February with this rather curious paragraph in it:

Those present at the meeting agreed to join a Future Direction Committee, tasked by the trustees of the RI to put forward their recommendations for this new vision. Chaired by Robert Winston, this committee is determined to come up with a vision that is shaped in consultation with the wider community, including the RI membership. In my opinion, this is our opportunity to create a national strategy for science communication, advocacy and public engagement if we want Britain to be the best place in the world to do science.

Note the rather telling reference to ‘wider community’ in terms of the RI membership and begrudgingly at that don’t you think?  Sort of counts you and me out then doesn’t it?  This is all very odd given the RI campaign message is, and I paraphrase, ‘save it for the nation.’  Er, would that be the same nation, that falls outside of the wider community?  Fingers crossed they show enough trust in the nation on whose behalf they act to ask us for some ideas on what could be done with Albermarle Street.  No, no, I promise to be constructive in a concreting-over sort of way (that’s a joke, promise).

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Deep down, you see – and I feel this ties all the above  together – is that I think many people in science would prefer a ‘best left alone’ way of working, it’s a sort of undercurrent behind lots of the things they say or do even when they are imploring people to help them out of monumental cock-ups from the past. This is only human nature I suppose.  But pity the poor underpaid communications teams in these organisations who have to manage such tensions on a daily basis.  Talking of which….

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There was a ‘best left alone’ essence to the broadside that Lords Willis, Patel and Winston fired at medical regulators in yesterday’s The Sunday Times (behind the pay-wall).   Lord Winston also did an interview on ‘The Today’ programme this morning which you may have heard.  The three highly-respected peers wrote that: medical regulation is slowing down science; there ought to be one regulator rather than the four we currently have and; we are wasting lots of money on multiple CEOs and communications people in these organisations, money which could be better spent on medical research.

What was weird about the letter – aside from the fact that it didn’t have any other backers even from organisations that the Peers are closely allied too – was that it read like a long-forgotten missive that had then been rediscovered and mistakenly posted without review.  The fact is, we are in the midst of significant regulatory reform in health research, the merger argument is not seriously on anyone’s agenda right now (even if, like me,you are sympathetic to it), and the line that burning quangos saves money just isn’t supported by the evidence.  It was all a bit of a surprise to me and others who thought we were beginning to reach a new regulatory settlement that was in everyone’s interests.

Then there was that stuff in the letter about salaries.  The easiest and cheapest shot to take at bureaucracy is always the one about overpaid staff.  It’s also the most difficult one to fend off.  But I can’t let it pass.  For while sometimes the criticism is justified and the question should always be asked about how our taxes are spent.  On the other hand, I could just as well be asking our research funders: can you prove beyond all reasonable doubt that every pound of the money you receive from taxpayers or donors is spent on medical research that meets patients needs and is not being wasted?  I’ve yet to see any funder be able do that I’m afraid.  And until they can, the wastage argument cuts both ways.  So, stones and glass houses and all that.

You know,  every story this last week – from the NHS to our food chain – points to the difficulties of regulating increasingly complex systems against a backdrop of constant change and with inherent challenges in terms of leadership, accountability and equity.

Medical research is no different.  Indeed, we have mountains to climb before we can say, hand-on-heart, that we have the sort of regulatory system for health research that patients and the public will expect in the future.  That’s where our efforts should be spent and we should leave no stone unturned in trying to achieve it, however much it might rile researchers and funders.  One day they might actually count their blessings that we didn’t leave them alone.

After two weeks away, this feels like the proverbial two minutes from time substitution that players do when coming back from injury.  Just to be sure we remember which goal we are attacking, mind.

I have a feeling that 2013 will very much be a year about how we regulate health research in the future.  More so than the last twelve months if that seems possible.  The Medicines and Healthcare products Regulatory Agency (MHRA) is consulting on its new corporate plan – details here.  Responses by 1 February 2013.

Which gives you almost a full three weeks to also prepare some thoughts about transparency and openness in clinical trials for the Science and Technology Select Committee inquiry.  Deadline is 22nd February.  I was pleased to see this is also on NIHR’s main website.

Can I confess to thinking that I wish the inquiry could have been led or perhaps better still, jointly steered with, the Health Select Committee given the important implications it has for patient care and treatment? I’m not sure the questions put before us by the Science committee quite capture that.

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.

Good to see a broad coalition of UK organisations including AMRC issue this joint statement today urging for the ongoing revision of EU Clinical Trials Directive to culminate in less bureaucracy for funders and others when setting up and running trials.

No one would argue with the need to put patient safety first but I have yet to see good evidence that the current regime with it’s many hoops to jump through has been a positive for patients.

But thinning out the regulations while maintaining public trust will require action both at home and in Brussels.

At home, of course, we await the arrival of the new Health Research Agency. Due to be set up as a Special Health Authority by the end of the year (the statutory instrument necessary to create it has been tabled today) people will be watching for early and key indicators of it’s tone and style as a regulator. These include who will be it’s first Chair and who will sit on it’s Board.