March 19, 2013

Political spotlight on Health Research Authority (HRA) intensifies ^Reply

clinical research, clinical trial costs, clinical trials, clinical trials data, Health Research Authority (HRA), HRA • Tags: AMRC, Association of Medical Research Charities, clinical research, Clinical trial, health research authority, HRA, medical research, National Institute for Health Research, NIHR, Science and Technology Select Committee

I am sure the new Health Research Authority (HRA) can take care of itself. But the expectations being heaped on it by others show no signs of abating. I wouldn’t be surprised if tomorrow someone calls on it to cure cancer. If it had been created by a Blair Government it would surely have been dubbed ‘The People’s Health Research Authority.’ Come to think of it…..

Why do I say this? Well, the committee of MPs and Peers looking at the draft Care and Support Bill establishing the HRA has just published its report; the Association of Medical Research Charities (AMRC) has provided an excellent overview of their conclusions here .

The key message from the committee is that the HRA should be ‘promoting’ research. I am sure this is right. But the very real problem for the HRA is how do you define this in practice? For the answer is potentially as long as a piece of string. There is certainly a real danger for mission drift if it’s not careful. There is also some irony in the fact that it was onlya few short weeks ago that three eminent Peers wrote to The Times criticising the HRA and other regulators for the amount of money spent on media and communications. Damned if you do, damned if you don’t (see my blog on this from just a few weeks ago).

Did anyone else also raise an eyebrow at the conclusion parliamentarians drew that there is ‘no single body promoting health and social care research?’ Er, the National Institute for Health Research (NIHR) perhaps? For one. It feels that the Committee has assumed the body language of funders and researchers when it comes to this thing called ‘promotion:’ quite simply they are good at promoting their own science but when it comes to promoting science in general it is rapidly becomes someone else’s responsibility. And often the responsibility of organisations that are already running on vapour in terms of resources.

Yet it is evident from the conversations I have had with colleagues thus far that generally they have been encouraged by the quietly efficient and logical way that the HRA is going about its business. It’s approach to public involvement seems sensible given the lack of precedence for where it wants to head. Its stakeholder event a few weeks ago was, by all accounts, excellent. It is steaming ahead with its pilot of speeding up approvals. These are all good things and it is important that we support their endeavour in the coming weeks and months if it is to become the fair but robust regulator we all wish to see.

Across the Committee corridor the House of Commons Science and Technology Select Committee has just published all the written submissions it has received as part of its inquiry into clinical trials. Some of these submissions are filtering into the press. And this evening I noticed this piece from Outsourcing Pharma.Com about the evidence of the Clinical Contract Research Association (CCRA). It again puts the onus on the HRA pulling things together. (By the way, I was just as interested in CCRA’s call to simplify consent and other complex processes which stand in the way of patients taking part in trials).

As it takes oral evidence, Committee members will focus in even greater forensic detail on the role of the HRA in promoting transparency in the registering and reporting of clinical trials. The Care and Support Bill Committee took a strong line on this and says HRA must lead the way. I would agree 100% with them. But HRA can only do this if it has strong political backing from the beginning and when it is having to face down the recalcitrant funder or researcher who won’t play ball. All on the basis that it is just ‘red tape’ preventing them from doing their life-saving work. For it is at those moments that the wind is often taken out of the regulator’s sails by a lack of courage of the part of our politicians.

So how the Committee chooses to deal with this particular issue is going to have an important bearing on the future workload of the HRA and how it is monitored in parliament. In the meantime, the Care and Support Bill will establish its formal role.

Yep. There’s no doubt about it. All eyes are on the HRA and this is just the beginning….

March 13, 2013

The lay summary is dead, long live the lay summary (#A2UComp) ¹

lay summaries, medical research, Open Access, science communications • Tags: @A2UComp, Academic publishing, Access to Understanding, AMRC, British Library, Communication, EuroPMC, INVOLVE, Laity, lay summaries, NIHR, Open Access, science communication, Scientist

‘They can’t write for toffee.’ ‘They’ being scientists of course. But like most generalisations, this statement is utter tosh.

You only had to be at the ‘Access to Understanding’ awards (#A2UComp) at the British Library on Monday night to realise that. The lay summaries that I and my fellow judges had been asked to review were of a very high standard. The winner, Emma Pewsey, is to be commended for beating off such strong competition. Sharmila Nebhrajani (CEO at AMRC) has written an excellent AMRC blog today on the whole competition if you are interested in learning more.

I very much doubt that scientists are much worse than any other ‘professions’ when it comes to their writing skills. And, in terms of resonating with the intended audience, success is as much predicated by the mindset of their author as their ability with the pen.

When I was a Head of Communications there seemed no end of graduates rolling up for jobs who would be able to tell you who fronted what TV programme . But they couldn’t write a news release to save their life. It wasn’t their often poor grammar or punctuation that mattered. It was more their inability to identify the story or the most important facts to communicate to their audience.

If I am honest I think that if I pressed a switch tonight and every scientific paper instantly became freely available online and with a good lay summary it would not make much of a difference to public understanding.

That’s not to say that we should not do it. But I simply think we should be realistic. Not least because I sense that technology and consumer behaviour will take us to a different place entirely as they so often do. Even some speechwriters now start off by first thinking what their speech would look like if summarised in a tweet. Should we ask our scientists do the same and to use this as part of their paper title, for instance?’

In the meantime, if we are to reach a better place with the writing of lay summaries then our approach to them must be more consistent. I am delighted that INVOLVE has been working on some NIHR-wide guidance and tools that will see light of day shortly. But i personally would also like to see us incentivise good practice by, for instance, only releasing grant monies when a good lay summary is agreed. I have tried this on some senior researchers and they didn’t seem to think it was too barmy. Well, no barmier than anything else I’ve suggested.

It is interesting that scientists and writers share a common tool – the notebook. Their livelihoods both depend on it albeit in different ways. One to allow replication. The other to feed creativeness ( although this seems a little too simple a distinction). The investment in its completeness is a mark of professionalism.

And I think that for me is why the lay summary remains such an important component of how we communicate science. It is less about the product itself than the discipline and behaviours it encourages: clarity of thought, appreciation of one’s audience, belief and conviction in one’s ideas.

The lay summary is dead. Long live the lay summary.

December 3, 2012

At last! A patient-centred statement on the proposed EU Clinical Trials Regulation ¹

ABPI, clinical research, clinical trials, EPHA, European Commission, European Public Health Association • Tags: ABPI, Academy of Medical Sciences, AMRC, Bad Pharma, BiA, Business, clinical research, Clinical trial, Clinical Trial Transparency Principles and Facts, Directive, EMA, European Clinical Trials Directive, European Clinical Trials Regulation, European Commission, European Parliament, European Public Health Alliance, European Union, regulation

First, a brief history of time in the Europe Union (EU).

It goes slowly.

That’s it!

For the last two years or so the European Commission has been consulting on plans to revise the European Clinical Trials Directive. The Directive has been in force since 2001. Researchers hate it. To be fair so do many patient organisations. The main complaint is that it slows down research into new drugs particularly in swotty Britain where we tend to do everything by the book and then bind it in gold leaf. That’s probably because of a) our schooling, b) we are brought up as subjects and, c) because of the same tendencies that make us enjoy queuing (select from the above as you see fit).

Over the summer the Commission published a draft proposal for new legislation or ‘Regulation’ for consultation and it is being considered by the European Parliament. Cue the usual confetti of responses from organisations and alliances of organisations stating what they do and don’t like. My basic summation of these responses thus far is that they think it’s much better because they won’t need any more gold leaf.

Last Thursday, the European Public Health Alliance (EPHA) – an association of non-governmental organisations from across Europe – issued its own revised policy position. It is to be applauded for being the only one I have seen this far which pushes the Commission hard to consider certain aspects of growing importance to patients in trials: the right to clear information; openness and transparency, and public involvement in all aspects of clinical trials. The following para taken from their website gives you a taster:

‘From this perspective it is also vital that clinical trials reflect the populations that are meant to benefit from them – for example women, older people and ethnic minorities – and that access to clinical trial data and reports is as open and transparent as possible, which implies full public disclosure in a central database to protect public health interests. Moreover, patients’ involvement in the process is essential; while this is foreseen in the present proposal, the extent to which patients will be able to influence the process still requires clarification.’

By contrast, this statement issued by UK commercial and non-commercial organisations could, and should, have taken a much stronger line on public involvement than it does. Particularly given many of the signatories, a number of whom I admire greatly and are highly supportive of the agenda. But public involvement is only really mentioned in reference to the Regulation’s proposed panel for reviewing trials. Such documents – jointly written and needing to be agreed by many – are often a difficult compromise. But this one does leave the impression that research is the dominant force, spinning a golden thread of ‘we know best.’

The UK has often set the international standard for public involvement in health research. So I hope this is not one of those examples of our country going to sleep on the job only to wake up and find that our European neighbours are way ahead of us. As I say, time passes slowly in Europe but not when you are asleep.

November 21, 2012

Royal College looks to boost child health research with children’s charter ^Reply

child health research, Medicines for Children Research Network (MCRN), NHS research • Tags: AMRC, Association of Medical Research Charities, BMJ, chairites and collaboration, Child Health, child health research, clinical research, clinical trials, donations to medical research charities, MCRN, medical research, Medicines for children research network, National Health Service, Neena Modi, NHS research, paediatric research, Pediatrics, research, Richard Smith blog, Royal College of Paediatrics, Royal College of Paediatrics and Child Health, Turning the Tide: Harnessing the Power of Child Health Research

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.

November 16, 2012

Text of speech to INVOLVE 2012 – Public involvement in research: would you like that shaken or stirred? ¹

INVOLVE • Tags: #INVOLVE2012, Academic Health Science Networks, AHSNs, AMRC, Health and Social Care Act 2012, Health and Social Care Bill 2011, health research authority, HRA, Iain Chalmers, INVOLVE, INVOLVE conference, Jackson Pollock, Jeremy Taylor, National Health Service, NHS Constitution, NRES, patient access to research, patient choice to research, patient data, public involvement in research, Research Regulation, Simon Denegri

Public involvement in research: would you like that shaken or stirred?

So, ladies and gentlemen, there I was on Saturday afternoon, at the pictures, watching the new James Bond movie, ‘Skyfall.’ This was background research for today you understand; listening to Adele dolefully sing: ‘This is the end’ which is the opening line of the film’s signature tune. And – as you do at these moments – I thought about public involvement in research.

‘We are certainly not at the end,’ I said to myself. ‘But we are definitely not at the beginning. Perhaps you could say that we are at the ‘end of the beginning.’’ And we are certainly in better shape than 007 begins the film. But perhaps I ought to come to the INVOLVE conference and, like Q, issue everyone a PPI pistol or lay review stun gun, better still, an Aston Martin to help us on our way?

Look out for it on the front of our next newsletter!

Not unlike 007, while the essence of our mission – putting patients first in research – has not changed over all these years, the context certainly has and more so today than perhaps ever before. That’s why I said yesterday, after Sir Iain Chalmers’ incredibly powerful and provocative keynote speech, that I thought this would be one of, if not the most, important INVOLVE conferences for many a year.

Since I spoke at the INVOLVE conference in 2010 we have had a spending review in which health research has fared comparatively better than most other sectors. But we have also seen a train of legislation on health and social care that has thrown up many anxieties. The boundaries of research and how it is conducted have also changed; the public’s role at these margins is often undefined, at best, and ill-considered at worst. We can be forgiven for feeling shaken, stirred or even both at various times.

Meanwhile we have ourselves been constantly changing attitudes and the way things are done as I think has been amply demonstrated by events here in Nottingham. This is where we started:

And, if you strip away some of the most obvious words we begin to get a sense of our preoccupations before the opening session.

The enthusiasm that has come across on twitter and in the general chat around the conference hall would suggest that people have come away inspired by what they have seen and the new connections made.

We know we have achieved a great deal but we also know there is much more still to do, much more. So, in terms of the evolution of public involvement I wonder where you would place us on this picture?

Standing tall perhaps? Some way off inventing the wheel I think? On the other hand it might just be that we are about to light the fire that transforms our health research system so that it truly puts patients first. If we are clear about our mission, our values and how we work together going forwards. If we work collaboratively and choose to make the most of the opportunities ahead of us. If we empower our colleagues to express their preferences about how public involvement is best poured rather than have it served to them ‘as it comes’ or refused because they are not seen as members of the club. And I think we are duty-bound to think and act opportunistically about the future however bleak we may feel at times.

Part of the team

How far we have come and, indeed, the dilemmas it can raise was brought into sharp focus for me when I did some reviewing – yes I do some real work occasionally – just a few weeks ago. This may have already happened to you but it was the first time for me.

It wasn’t that a number of applications included patients as co-investigators or co-applicants. Or that many quoted INVOLVE’s guidelines and some had actually read them! Nor that others went a bit overboard with some aspects of their PPI and advocated hundreds of focus groups to alter the design of a petri dish. I exaggerate but there were some points when I thought to myself ‘oh gawd’ what have we started a bit like the owner of Fenton in Richmond Park.

No, it was that several of the teams who came along to present their application brought a patient or carer along with them to answer questions. All excellent you would think. But in the room several things went through my head. Is this simply clever marketing – a new bit of game playing to tick the box? Are we being pitted against one another? How do I ensure their voice is heard by my fellow members? How do I establish the sort of dialogue in such a short space of time to establish that they feel genuinely part of the team?

Values

Well, of course, the answer to this dilemma as to the many others we face in public involvement is that we must turn to our values to guide us. I am indebted to a good colleague who sent me a publication by Community Links which summed up the importance of values as follows:

Values are the beginning – they are what inspire us
Values are the means – they are what we do and how we do it
Values are the end – they are what we strive to achieve

And the fact is that we must return to them time and time again, be honest with ourselves when we have failed to uphold them as well as applaud ourselves when we have.

In 2007 INVOLVE set out how it approaches its work. But these are not values and now – given our growth and the external pressures we face – the time seems right to invite you to help is crystallise a set of values that will guide us in the future. So, following this conference, as part of a survey, we will be asking you to help us identify what you think these values should be. I would hope that both the process and the outcome will be unifying.

Frontiers

For me personally, one of the most important values to run through our veins is a commitment to work collaboratively with others. We are not and should not behave like the conqueror wishing to take over some fortress or build a new one. Rather we should, with others, strive to create a different space where research can happen, one which is much richer and more rewarding in meeting patient needs and priorities in the future. This spirit of partnership will be important in tackling some of the uncertainties ahead.

So let me set out what I think some of these challenges are and suggest some ways forward.

Changes in health and social care

First, are the changes sweeping across our health and social care system following the passage of the Health and Social Care Act earlier this year. Some of you may have heard Jeremy Taylor from National Voices share his perspective on these yesterday.

Now, if you are in the communications section in the Department of Health, you tend to see the world like this:

I love the unbridled optimism inherent in its neatness don’t you, although it is actually a very helpful graphic when you study it? Of course, depending on who you listen to about the NHS reforms, you are likely to come away with one of two pictures much as we do when faced with an optical illusion.

But, let’s be honest, most of us feel that things look like this at the moment, don’t we?

Jackson Pollock – who painted this picture called – said: ‘My paintings do not have a centre, but depend on the same amount of interest throughout.’

So perhaps our task is similar – to look at things in a different way to that which we are used too. It’s not so much about looking for the focal point or foci anymore but identifying where and how we build and support networks to ensure the patient and public interest permeates it all. I share the concern that public involvement is already a curate’s egg with places where it is good and those where it is poor or not-existent, that this may be amplified as the picture unfolds.

But on the other hand statements by Malcolm Grant, the Chair of the NHS Commissioning Board – who was recently quoted as saying that ‘patient experience’ is the Board’s most important concern – and others, give us license to roam and forage in ways that we could not have before. The question for us is where do we roam and what are we foraging for?

What I’ve heard from many of you is a desire to use the current state of disruption to forge new alliances with our public involvement colleagues and others in service provision for instance; to map what is happening in public involvement and; to ensure public involvement is central to the workings of new structures such as the Academic Health Sciences Networks (AHSNs) and integrated clinical research networks. Some of this work we are already taking forward in INVOLVE’s task and finish groups. But the latter one with regard to making public involvement integral to the governance and accountability of networks – to help our colleagues ask challenging questions – is an issue that was also raised by our members at their last meeting in September and which is now an urgent priority for us.

Patient choice

Let me now turn to the issue of patient choice in research.

The irony of the new Health and Social Care Act 2012, given its difficult birth, is that from a research perspective it holds much promise. There are duties now on all local NHS organisations to ‘promote and advance’ research. Evidence, patient outcomes and quality are in the ascendancy as drivers of change or so we are told. Patients will have new levers and some improved ones to exercise their choice to take part in relevant and appropriate research. These include the NHS Choice Framework on research and the revised NHS Constitution. The aim is that being part of research should be seen as an integrated part of a patient’s care and treatment. And again, I think the alliances we build with our colleagues across health and social care provision are going to be powerful in making this happen.

Our priority at this point must be to ensure that improving patient access to research is not interpreted solely as a recruitment drive for clinical trials and other studies. It needs to be defined in terms of patient outcomes; shared decision-making and knowledge exchange; the information, evidence and tools at people’s disposal to make an informed choice; the stories of other people’s experiences in research; and of course the role of public involvement. Public involvement is going to be integral to delivering this agenda in a way which is as much shaped by as it does match patient preferences. In simpler terms it is called moving things closer to the patient.

But perhaps we also need to go through an attitudinal shift in seeing greater participation and engagement as very important consequences, rather than the difficult cousins of, public involvement as we sometimes do.

Can I also add as an aside that, given my other role with NIHR, that it has been very interesting and helpful to me to hear the many perspectives about the impact of research regulation on public involvement and patient access to research. We can certainly feed this into the work that INVOLVE and others are doing to both forge a good relationship with the new Health Research Authority (HRA) and shape the environment so that it ‘protects and promotes the public interest’ – which is the HRA’s mission statement.

Patient data

There has already been a great deal of discussion at the conference about the use of patient data for research purposes and INVOLVE has long been involved in this debate, most recently giving evidence to the Caldicott2 review on information governance in health and social care. We will also be responding to the Government’s public consultation on its proposals for a modified NHS constitution launched last week.

In all our representations about this – whether they have been about access to medical records for research or the potential of ‘big data’ as it is often termed – INVOLVE has stressed the importance of putting the patient first, most obviously in terms of security and confidentiality.

However, thinking ahead, the task is now one of articulating the additional or equivalent rights and expectations that should flow to the patient: being able to control their data in ways which will be familiar to them from other aspects of their ‘online’ life; accessibility of course; a commitment to support them to use data to help prevent ill-health or manage their condition and; to access clinical trials and other data upon which their treatment or care is based.

Rights and expectations

The consultation on the NHS constitution gives us an opportunity to set out this ‘quid pro quo’ for patients. But I also think that the time has come to – in fact it is well overdue in my opinion when you think that people like Andrew Herxheimer made this same case in 1988 – to lay down the rights of patients in research, a charter which would set out some basic expectations on information, consent, dignity and respect, and feedback from researchers.

The fact is these are perennial issues we have long been concerned about but where the discussion and debate has meandered rather than coalesced. I would hope that such a charter might give it a new centre of gravity for the future.

Given the global nature of research nowadays – and who can not be affected by what we have seen happen in places such as India – I would hope that this is something our partners and colleagues in other countries would work with us on and, with it, develop a much firmer international partnership of public involvement organisations. That is very much in my line of sight.

Funders

Finally, I do briefly want to talk about funders and institutions. Now, some of you will be familiar with the joint publication by INVOLVE and the National Research Ethics Service (NRES) published at the end of last year.

The report was an analysis of the public involvement component of grant applications put before NRES. The essential story to take from this is that National Institute for Health Research (NIHR) funded applications were far better in terms of their public involvement component than those funded by charities, the NHS, industry or others.

We have been fortunate in the UK that such a sizeable portion of the Government’s health research budget rests with the one organisation – NIHR – that has embraced public involvement in research from its establishment in 2006: to the point that it can be the deciding factor in whether a grant is awarded or not although we still have much work to do. As INVOLVE’s funder it has also given us a stable and sustainable base from which to work.

But the further afield you look the more disappointing the picture becomes.

Thinking about the researcher’s comment earlier, we need to raise our game with how we engage with and make the compelling case for change which will make them sit up and take notice whether they be charities or industry.

Remembering my own time as Chief Executive of the Association of Medical Research Charities (AMRC), it was interesting to see how its influence with Government grew in tandem with its ability to better tell and quantify its contribution to the overall enterprise. Anyone reviewing the abstracts from this conference will see how seriously we take the business of impact but perhaps we are not thinking through those impacts so that they resonate most with the preoccupations of our key audiences – the agenda around growth, the forthcoming Research Excellence Framework (REF).

Frontiers

So these are some of the frontiers in public involvement as I see them. And you will have a chance to identify the priorities you think INVOLVE should take forward in the future in our follow-up survey to the conference that I have already mentioned.

I am also sure that there are many different actors who will play a part in helping us navigate them – and you in this hall encapsulate this: those who strike it out alone by necessity or choice and bring back messages of new things found or not!: the wagon trains of communities who will circle at regular points on their journey before settling in one place; the evangelicals who are good at spreading the word and; the road or rail builders who begin to bind and grow the communities that set out ahead.

Who can be in any doubt for instance about the perennial power of the personal story to shift people’s thinking and improve practice after this conference; or when you read articles as powerful as the piece by Matilda Hale, Professor David Jones and others published in the BMJ just a few weeks ago.

It is about having mutual respect for what each of us can do from our respective positions and their inherent limitations as well as opportunities. To know what each other is doing and how it contributes to the whole.

How we are organised?

So we do need to consider how we organise ourselves and come together in the future. It is very clear that we are faced with some real development needs or growing pains in terms of our capacity and capability– the size of the community now being called upon to do ever more in the name of public involvement, the variability in public involvement, their skills and development, building networks, the extent to which knowledge is shared between us.

INVOLVE cannot do it alone in fact by working ever more closely with you and you with us will we turn the community represented in this room into a wider movement. But nor should we be afraid of looking at new ways of working as we have already begun to do in INVOLVE with our project groups.

Thinking about my weekend trip to see the new James Bond movie and the thoughts it had prompted in me about public involvement, as you’ll know, James Bond is fifty years old this year and has been through many transformations. But we still know it is James Bond because of the recognisability of the values he stands for and his various trademarks. So it can be for us.

I was heartened when someone in run-up to this conference, said the INVOLVE conference used to be the only place to come to and now it is the place to be. As Chair that is music to my ears. That we are able to provide a safe environment where people can share their personal stories and draw strength from others, where we can all pause and reflect on how we approach the future is something we need to hold onto. What did Abraham Lincoln say:

‘If I had eight hours to chop down a tree, I’d spend six hours sharpening my axe.’

He also said:

‘You can not avoid the responsibility of tomorrow by evading it today.’

Conclusion

Our values, collaboration, rights and expectations, asking challenging questions, how we are organised, these are essential building blocks in how we grow in strength as a movement and take the initiative. For me they are the means for arriving at a point where the choice in public involvement is not about whether it happens, but how it is best served to improve the quality of research so that it meets the needs of the public and patients

Mine is shaken. With ice and a bit of lemon. What’s yours?

November 1, 2012

Diabetes and cancer network reports on engaging people about clinical research and more… ^Reply

clinical research, clinical trials, medical research, public engagement, public involvement • Tags: Action on Access, AMRC, Ann Blandford, Association of Medical Research Charities, Biotechnology and Pharmaceuticals, Business, clinical research, Clinical trial, Diabetes Research Network, impact of public involvement in research, INVOLVE, INVOLVE annual conference, National Cancer Research Institute, NCRI Consumer Liaison Group, NHS research, research

My thanks to the Diabetes Research Network (DRN) for sending me their report ‘Improving public awareness of clinical research.’ Clinical research networks are at the ‘front-line’ in terms of encouraging people to take part in research and this report gives a good insight into some of the tools and strategies used by DRN. Others trying to do the same thing might find the report helpful in enabling them to shortcut a few steps. There’s also an honest appraisal of the hurdles they have had to overcome and those that remain in the way.

Similarly, the National Cancer Research Institute (NCRI) Consumer Liaison Group have today posted a new report on their website called ‘Action on Access.’ This is also stuffed with case studies and learning that will be useful to many. But there are also very good conclusions directed at commissioners, Trust Chief Executives, research funders and others. While I think about it the group have also posted a report on the impact of public and patient involvement and it’s here if you wish to take a look.

On the same theme, AMRC are holding a ‘Research in the NHS’ event on 10th December. Places can be booked here. I believe I am speaking but don’t let that put you off.

Fellow blogger Jo Brodie referred me to this posting by another blogger Ann Blandford looking at how the focus on ‘do no harm’ in research regulation, disincentivises researchers such that the system ends up doing no good either. Or that’s how I read it anyway. Ann talks about the need for ‘proportionate’ regulation which is the hot topic of the day. Only this afternoon I was discussing with colleagues how public engagement strategies for recruiting patients to research can often fall foul of the different interpretations and then stipulations put on them by research ethics committees. That’s surely one for the new HRA feasibility study as announced this week.

Less than two weeks to go until the INVOLVE annual conference and the conference issue of the Newsletter is now out. Please take a look. The INVOLVE blog will be going live soon as well. We have 450 delegates attending and a real buzz is gathering about the whole event.

September 27, 2012

Round round get around I get around – Caldicott2, patient data, dementia portal and more! ^Reply

AMRC, Caldicott, Dementia Challenge, NHS Commissioning Board, NHS White Paper • Tags: Academic Health Science Networks, AHSN, AMRC, Cancer Research UK, clinical trials, Greater Manchester, Guardian, King's Fund, MHRN, National Health Service, national portal for dementia, NHS, NHS Commissioning Board Draft Mandate, NHS Trust, NHS Trust R&D, NIHR, Patient, patient choice in research, patient data

So sang The Beach Boys who were on Radio 2′s ‘In Concert’ this week. Not that I’m a great fan but it seemed apposite given my week. This has involved visits to TrialReach, Oxford (well, virtually!) to discuss plans for public involvement in the Biomedical Research Centre there, my good colleagues at BioMedCentral and, tomorrow, Leeds (see below). To think I used to spend three weeks every autumn to attend the party conferences. It’s like regaining a bit of my life again.

But before I get into the meat of this blog, I just thought I’d draw your attention to a presentation on the ‘Caldicott2′ website (this is the review looking at information governance in the NHS including use of patient data for research purposes). Made by Dame Fiona Caldicott earlier this month it shares some early findings from the review and also shows the next steps for this important piece of work. Look under the Southern Informatics listing on this page.

I’m off to Leeds tomorrow to speak at an NIHR regional event – the first of four happening over the next few weeks – aimed at strengthening dialogue with NHS Trust R&D Managers against the background of much change in the NHS. I am looking forward to getting to know this audience better and hope that, during my small walk-on part, I can convey the important role they play in delivering research which will lead to better outcomes for patients. I think I am erroneously listed as ‘a patient’ on the programme and am wondering whether that means I take on the even more misleading definite article on the day, and am then definitive in every sense of that word thereafter. Let me worry about that one.

I notice that several organisations have been pushing out their responses to the NHS Commissioning Board Draft Mandate (it being the deadline). The King’s Fund document is compelling as ever although, as always after reading their documents, I felt a bit as if I should have taken that further degree after all. It has a strong statement on ‘shared decision-making’ which succinctly conveys what this should be in practice.

The Association of Medical Research Charities (AMRC) has joined forces with other research funders to put in a very comprehensive response focusing on the research and innovation objectives in the Mandate. Some good ideas in there including the point about better training for NHS staff on research, a point that was also made by Jonathan Sheffield (NIHR Clinical Research Networks) during The Guardian debate on innovation this week. It’s certainly true that if patients are to see choice become a reality in research we need to do much more to make sure that NHS staff are ‘research-aware.’ Meanwhile I thought Cancer Research UK’s response was helpful about ’patient choice’ saying (briefly) what needs to happen to make it work and what they might be able to contribute. I think this is the key – organisations understanding that in this new environment what is pushed from the outside is going to be as, if not more, important, than what is put out from the centre. And I sometimes wonder whether the sense of shared responsibility has quite sunk in in some quarters.

Tangentally you might want to check out the blog I have written about patients and Academic Health Science Networks (AHSNs) for the Greater Manchester (AHSN) website. Last week at the INVOLVE annual symposium for members it was interesting to hear people talk about their different experiences of working with AHSNs. Helping support their work in trying to avoid groundhog day in these new organisations, is going to be a focus for the future I suspect.

This afternoon I tweeted about the national portal for people with dementia and their carers to register their interest in taking part in research and be informed about future trials. It is being developed by DeNDRoN and will be developed shortly. This really could be the most significant development in helping to nurture a research-active patient community since the Alzheimer’s Society set up QRD in the 90s. The opportunity of the PM’s Dementia Challenge to give it the best start in life should not be missed and I’m looking forward to chairing the public involvement group that is going to help guide the portal’s development.

Seem to be on the road a lot from next week as well and look forward to meeting people in Birmingham at the next NIHR Regional R&D Day, the Mental Health Research Network (MHRN) conference and other places. Reminds me I must buy Ben Goldacre’s new book to read on my travels. And this from the US Federal Drugs Administration today seemed relevant.

June 25, 2012

New science networks herald more fertile ground for health innovation ^Reply

Academic Health Science Networks, AMRC, BHF, Caldicott, Health Research Authority (HRA) • Tags: Academic Health Science Network, AHSN, AMRC, BHF, British Heart Foundation, Department of Health, Derek Stewart, health research authority, HRA, Janet Wisely, medical research, National Health Service, NHS, NHS Innovation, YouGov

If contemplating NHS change rest assured, and this from one who once visited Mt Etna, that the lava does solidify, some old structures do survive, and it is possible for new ones to be built with solid foundations.

Herewith some new and some not so new ‘kids’ on the block in the world of research.

First, great to see that my good colleague and patient advocate, Derek Stewart, has started his own blog and has got off to a predictably brilliant and incisive start with a piece entitled: ‘What I want from research.’ I’ve also listed his site on my blog roll (see below).

The British Heart Foundation (BHF) has a new report out today entitled ‘Clear and Present Data.’ It examines how use of patient data is integral to medical research. There’s a youtube video available through the above link and BHF have also published the results of a YouGov survey of public opinion on patient data issues. Suffice to say that this is all part of a significant push by the medical research charity sector on patient data issues – it is, for instance the theme of AMRC’s parliamentary summer reception on 12th July.

The BHF report makes six recommendations including introducing an opt-out system for use of anonymised data in research (already a Government proposal subject to the outcome of a public consultation later this year), and changing the remit of Caldicott Guardians. Not sure about the last one – I would need to think it through from a patient perspective in the context of a ‘localised’ NHS. But good to open the debate. For the results of the survey and an overview it might be easiest to read the guest spot on the Association of Medical Research Charities (AMRC) blog by Joe Clift from BHF.

A number of BHF’s recommendations are focused on the HRA, so a brief ‘congratulations’ to the excellent Janet Wisely who was recently appointed Chief Executive there and has really taken up the public involvement challenge.

Finally, the entirely new kids on the block are AHSN’s or Academic Health Science Networks.

The Department of Health published a guidance document about their formation on Friday, and potential networks have been asked to submit ‘expressions of interest.’ AHSNs really do represent a significant and positive enhancement in terms of where research meets the NHS. It is not so much what they are as an entity as what they will bring together in terms of local NHS organisations, academia, industry, providers etc behind a common purpose. It is also the comprehensiveness of their remit given that they will not just be responsible for the diffusion of innovation but also the promotion of research including trials and public participation. I suspect more change will ripple outwards. The Governance arrangements will, however, need to be strengthened with strong public involvement mechanisms.

Perhaps AHSN’s represent new lava flows in research bringing more fertile grounds for growth with them.

June 19, 2012

The life sciences, the public and the growth agenda…its not just about bums on seats ^Reply

AMRC, Cancer Research UK, clinical research, clinical trials, collaborations, Comprehensive Spending Review, David Willetts, Government's growth agenda, Health and Social Care Bill, Health Research Authority (HRA), Life Sciences Strategy, medical research, medical research charities, Office for Life Sciences, patient and public involvement, Public attitudes to science survey 2011, public engagement, public involvement, Research Excellence Framework, Science and Society, Science is Vital • Tags: AMRC, Association of Medical Research Charities, Cancer Research UK, Charitable organization, David Willetts, medical research, Medicine, NHS

This is an extract from a talk I gave on Monday to the Faculty of Medical Sciences at the University of Newcastle. I tried to answer the following question:

The life sciences are seen as fundamental to the nation’s health and to economic growth. But what is the public’s role in making this happen?

The alternative title is ‘Not just bums on seats’ for reasons that will become clear. I should add that, prior to my lecture, I had the opportunity to discuss the Faculty’s public engagement strategy with senior staff and colleagues and would like to thank them for their warm welcome and hospitality throughout the day.

Introduction

Over the next hour I’d like to explore with you why I believe a partnership between the life sciences and the public is fundamental to the former’s success in meetings its aims to improve the nation’s health and wealth; that our efforts as partners and as part of the growth agenda, must be conceived of as a joint enterprise.

I shall also argue that the life sciences needs to understand the distinct partnership roles that the public can and wants to play: as funder and advocate, participant, citizen, co-producer and trustee, before we can make the most of the opportunities that lie ahead. Only when we support these roles so that they are mutually reinforcing will we make the most of the opportunities ahead. Indeed, I would argue that the most successful science organisations will be those that understand and reflect this in their strategies and plans.

The public as fellow advocates

Why does this partnership matter, and why should it matter now more than ever? Well, let’s turn first to the role of the public as funder or donor, and as advocate.

As you may know, word is beginning to spread across Whitehall and Westminster if not wider, that the next public spending review is likely to take place a year earlier than expected. Also that, if the last spending review was felt to be uncomfortable, then the one about to land upon us is going to be even more so, with science facing a sterner test of its resolve.

The life sciences fared comparatively well to other sectors of the economy in the 2010 spending review. That was not just because of the level of funding but also because of the continuity of approach in terms of policy and direction with what had happened under the previous Government. This political commitment to life sciences has been sustained in the months since. Only last week the Science Minister, David Willetts, said in a guest blog for Cancer Research UK:

‘The life sciences are at the heart of this Government’s plans for sustainable economic recovery.’

In December last year we saw the publication of the Government’s life sciences strategy with its ambition of making the UK ‘a global hub for the life sciences’ by supporting a collaborative ecosystem, reducing regulation and driving innovation through ‘clusters’ and ‘catapults.’

A good part of that strategy – and what has happened since – has been devoted to enabling more research to happen in the NHS through: regulatory change – including the setting-up of the new Health Research Authority (HRA); enabling better access to patient data for research purposes; strengthening the rights of patients to taking part in clinical trials as part of their choices around care and treatment and as a right under the NHS Constitution; and establishing a new statutory duty on all parts of the new NHS to ‘promote research’ during the passage of the Health and Social Care Act.

None of this, of course, means that science generally will not face the same questions about impact, value, return on investment, the difference it has made to people’s lives, that it was challenged with last time.

In fact, one of the problems we will face is that the stories and evidence used last time will have likely devalued as a currency with HM Treasury and others simply because they will have heard them all before. A premium will be put on new evidence but also, perhaps, on similar evidence being presented with a next instalment that is compelling in ways which will persuade its listeners that they should support the authors to write another chapter of, better still, a new edition.

It is also going to take more than the vivacity of a ‘sectional’ ‘Science is Vital’ campaign or a science-only platform in the shape of the excellent ‘Geek Manifesto’ by Mark Henderson to win the argument. Science must better connect with the wider public if it is to make its existence and better still, its strengthening, of political expediency.

But at least we start in a potentially strong place on this too in respect of health research, in the shape and form of our medical research charity sector. Medical charities – as represented by the 125 strong membership of the Association of Medical Research Charities (AMRC) – collectively raise and fund over £1 billion of research in the UK every year. That figure is double what it was just over six years ago. Charities now represent over one third of all publicly-funded expenditure of research here in the United Kingdom, a situation that is unparalleled anywhere else in the world.

Given that the majority of these funds are raised from the British public – about £2,500 a minute by my calculation – charity is an important symbol of the public’s interest in research. Medical research is the leading charitable cause to which people give (in spite of a recession) in the UK – only the Netherlands has a higher percentage of its population raising money for research. And all the evidence suggests that the public see a donation to research as being of immense in making a difference, and stands as a good counterpoint to the argument that the public are semi-detached from research as an activity.

The other deliberate reason for pausing on charities for a moment is to ask you to consider one other important feature of their rise. The growth in charities as research funders has gone hand-in-hand with an increasing assertiveness on key issues in science – from hybrid embryo research to the Health and Social Care Act. It has been driven very much by those charities which are in turn propelled by a strong and active patient group or patient constituency by their side, knowledgeable not just about their condition or that of a loved-one but also about the research that is important to it.

And yet, for all this, it would be wrong for science to see medical research charities as a surrogate for true engagement with the public. Or believe, as I fear it sometimes does, that money donated is symbolic of an open-ended commitment to it by the public. Or as an illustration, case study or human interest story to be manipulated to make its case. The challenge is for science to make its own connections with the public as a fellow advocate.

That is no mean feat. For science will need to shift its philosophy from seeing the public as a crowd that needs to be educated, to a potential source of support that is to be carried with it. A friend of mine who used to produce rock festivals recently told me that the first act in the field to be used as a venue is to arrive and wait for the BT person to arrive and put in a phone line. The rest all stems from this. I sometimes look at what we do in science communication and what is passed off as engagement and wonder if we have only just got past that first act, with the phone line in place but with only the occasional incoming call being accepted.

The public as participants

Now that I’ve got that general point off my chest I wanted to turn to the part that I believe the public can and want to play in making health research an engine for wellbeing and growth. For I hope the most important reason for developing our partnership lies not with the need to make a political point, but more in the belief that we can achieve greater things to improve people’s lives if we work together.

The Prime Minister’s Life Sciences Strategy statement is as good a starting point as any for this part of the discussion because of the desire he expressed that every patient should see themselves as a research patient – as demonstrated by their willingness to share data with researchers and ultimately in taking part in trials: the ultimate goal being for the UK to remain a leading centre for clinical research in the world.

My role as NIHR National Director stems from a recognition within NIHR that, having established a world-class infrastructure for research – the supply side, we must now pay more heed to the ‘demand-side,’ that is creating more ‘pull-through’ of patients into research – including, but certainly not exclusively, clinical trials.

Generating this public demand for taking part in research will mean giving better information and tools to patients to find out about, and ask their doctors, about research such as the UK Clinical Trials Gateway (UKCTG). It also means better information and tools for clinicians. But, most of all, it will require an NHS system more set-up to meet this expectation than has hitherto been the case. Last month, on International Clinical Trials Day, NIHR CRN CC published a survey showing that:

Only 21 per cent of people surveyed were aware that carrying out research is a key activity for the NHS, yet…
82 per cent of people surveyed said it is important for the NHS to offer opportunities to take part in healthcare research and…
Less than seven per cent of people surveyed said they would never take part in a clinical research study.

The public appetite to take part in research would clearly seem to be there. Yet the picture is very patchy indeed when it comes to NHS Trusts that are geared-up – as one NHS Trust aspires – to offer every patient who walks through their door, the chance to take part in an appropriate clinical trial. The new NHS presents both challenges and opportunities to change this and the focus of our attention must be on the ecosystem that exists around a Trust. That is why initiatives such as VoiceNorth and the local collaborations it can build are going to become more and more important in the coming months and years.

But we will miss many opportunities if we take a ‘bums on seats’ approach to this agenda and define public participation only by the number of people who take part in trials. Clinical trials can only be a high visibility cloak for the participation agenda. They do not in themselves tell us much about the degree to which we have created a research-active population.

Citizens, citizens, remember we are citizens

Just last week I was talking to some colleagues about the degree to which research participants are kept at arms-length in many cohort studies, studies which often ask their public to sign-up for life so as to generate new data and learning to improve health. The reasons for this are many and some are well-founded, but not without solution.

The opportunity missed is that of learning from people how these studies might evolve, adapt and share over time in keeping with people’s lives and needs. The risk is that, before too long, people who see themselves as consumers with rights in every other aspect of their life will begin to feel somewhat used and abused, word will get round and researchers will metaphorically see doors closing as they turn into the street. The same is true in clinical trials where many patients find a frustrating lack of attention paid to basic ‘rights’ such as the right to receive feedback on the results of a trial and what it means.

In this, as with all research, we need to begin to see people not purely as participants but as citizens, members of a community who have rights as well as responsibilities in the name of pursuing new knowledge. Indeed, citizenship is how we should frame the relationship between researcher and patient. Citizens, citizens, remember we – both you and I – are citizens.

The public as co-producer

The other role that the public can play in making life sciences a driver of economic growth and the nation’s health and well-being is as co-producer.

We now have a growing body of evidence – the starting point for which is encapsulated in the 2010 NIHR/INVOLVE report ‘Exploring Impact: Public involvement in NHS, public health and social care research’- that involving the public can help strengthen research design, shape research strategy and agendas, execute the research efficiently and disseminate its findings to a wider audience.

Whether it is the prostate cancer trial that was saved from failure once patients were involved in the way the trial was articulated to potential participants. Or the James Lind Alliance Priority Setting Priority Setting Partnerships approach that is now embedded in NIHR and brings together patients, researchers and clinicians to identify priorities for research. In fact in many other countries the UK is considered so good at this stuff that they think it is the land of milk and honey – to quote a colleague of mine.

But in spite of the many successes that we – INVOLVE and its partners – have to our name, we also face significant challenges. In fact the task ahead is best encapsulated with two pieces of evidence. The first is a paper published in 2009 by Rosemary Barber and colleagues – Rosemary is a member of INVOLVE – based on a survey of almost 1,000 health researchers. It showed that less than one fifth had involved the public in their work and that many of those surveyed were deeply apprehensive about public involvement on a number of scores.

The second piece of evidence is from a report that INVOLVE published with the National Research Ethics Service (NRES) at the end of last year. This examined the extent to which public involvement featured in research grant applications coming before ethics committees. It then looked at the funder of each of these.

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 considering their basis of support, and industry seemingly having no knowledge that there is a public out there at all!

An interesting post-script to the industry story is of course that, as its representative associations and others have tightened up the rules on what it can or cannot do to inform and contact patients, so it has pulled away from even the most benign public engagement activities. But that is a story for another day.

From an INVOLVE perspective, the main challenge continues to be individual and institutional attitudes if not outright resistance to public involvement. Understanding the reasons for this and determining the best way to tackle it is something you may well have views on today. The opportunity for me seems to be how we might move co-production out of the handcuffs of what happens in the traditional peer review process and its obsession with lay membership and patient representation, to using new technologies and social media to gain a wider view and insight from the public at all stages. We need to think differently and more creatively about this stuff.

The public as trustee

There does seem one final way in which the public and researchers can find mutually beneficial ground on which establish a partnership.

I know that ‘Impact’ – particularly in the context of the Research Excellence Framework (REF) – is a highly popular topic of conversation in universities. It is also very much on the public involvement agenda as well. Whereas you fire brickbats, we are still at the stage of scratching our heads to some degree. What is the evidence? How can we best demonstrate it? How do we define value? Should we bite the bullet and begin to crunch some numbers if I may mix metaphors for a moment? And I am sure we have much to learn from you and other colleagues on how best to tackle this agenda.

But given the rise of ‘Impact’ as an agenda, and the inevitability with which Government is likely to ask for evidence of the soundness of its investment in science it would appear absolutely essential for science and its public to be working together to articulate this value. And that brings me back full circle to the role of the public as fellow advocate.

And yet it is more than that. It has always seemed to me that the ideological blind-side of science when it comes to public involvement has been its failure to see it as protective air cover for the sort of political storms and difficult public debates that do come along more regularly than would we wish.

Even if people find it difficult to accept public involvement as a value-add in terms of the quality and relevance of science, then the societal trends towards ever greater scrutiny of what those who receive taxpayer and public funds do in its name, should surely point to the need to involve the public as part of good governance and accountability to instil wider public confidence.

Close and conclusion

If you were to ask me for a vision of the future it would be as follows:

- For citizen-driven research to be seen as integral to the the UK’s health research ecosystem, a way of doing research which brings many partners together including the public to derive ever-greater value out of what we all do, and where there is mutual respect and acknowledgement of respective roles and expertise.

- A health research system in which all our public funders have public involvement as a driving philosophy for the way they work.

- And an NHS in which patients are challenging their Trust and doctor to make real their right to participate in research as part of their care and treatment.

I hope today that I have given you good grounds to see the public as an important partner of the life sciences in meeting its ambitions, in also setting out the many roles the public can play to this end.

I said at the beginning that the best chance of success will come if we see these roles as mutually reinforcing and find ways to make that happen. Equally, the most successful science organisations in the future will be, I believe, those that offer diverse opportunities to the public to be a partner and allow their public to switch between these roles according to the needs of the time. My sense is that you are thinking along the same lines here at the Faculty.

May 19, 2012

Thoughts on public involvement, participation and engagement in research…from Denmark ¹

INVOLVE, public engagement, public involvement • Tags: AMRC, Association of Medical Research Charities, Chief Medical Officer, COPENHAGEN, Denmark Health Forum, medical research, Medical Research Council, National Institute for Health Research, NIHR, public engagement in research, public involvement in research, public involvement in research in Denmark

Those of you who follow me on twitter (and you can do so by clicking on the twitter symbol on the blog), will know that, earlier this week, I was tweeting from Copenhagen in Denmark.

Myself and Derek Stewart, Associate Director for PPI at NIHR CRN CC, were there to help launch the Danish Health Forum’s public involvement plan. By the by, Derek has started a very interesting debate on Linkedin about what new technologies mean for the future of public involvement and I encourage you to take part – you will have to join first if you are not a member of Linkedin, but it’s free.

Anyway, here is what I said on the day…more or less!

COPENHAGEN – MAY 2012

Ladies and gentlemen, good afternoon.

May I begin by congratulating you on today’s annual conference. This event is clearly a very important milestone in the advancement of public involvement in health research in Denmark and it is a very great privilege and honour to have been asked to open proceedings.

I am also very pleased that over the past few months and years you have sought the thoughts and guidance of INVOLVE and our partners in public involvement in England and, on their behalf, can I say how much we look forward to continuing to work with you as close colleagues in the future.

INTRODUCTION

Perhaps I should begin by telling you a little about myself. As you will know from your programme, I am Chair of INVOLVE – the national advisory group for the promotion and advancement of public involvement in research – which is funded by our National Institute for Health Research (NIHR). I am also the recently appointed NIHR National Director for Public Participation and Engagement in Research.

Prior to these I was the chief executive of the Association of Medical Research Charities (AMRC), an umbrella group which represents about 120 charities who collectively fund about £1.2 billion of medical research in the UK each year.

As you might guess, many of AMRC’s members are also well-known patient groups and it is with one of these – the Alzheimer’s Society – that my own public involvement story began, way back in the early nineties. At that time, it was one of the first of our charities to begin to seriously champion the public involvement agenda with the establishment of its patients in research network called Quality Research in Dementia or QRD.

INVOLVE

Mogens has asked me – over the next 15-20 minutes – to reflect on the UK’s experience in public involvement, after which I am very happy to take questions.

That is quite some task!

So, rather than a timeline of key events, I have chosen to tackle the challenge by looking at what have been the fundamental strengths that have made a difference to advancing public involvement in my country. I am then going to look at some of our current challenges and opportunities and finish with some ambitions for the future.

To start, I thought it would be helpful to begin with the present day. For, what INVOLVE is, our role and what we do, in itself can tell us a lot about how we have evolved and why.

As I have said, INVOLVE is a national advisory group funded by our Government through the National Institute for Health Research (NIHR) for the promotion and advancement of public involvement in all forms of research. We define public involvement in research as research that is carried out ‘with’ or ‘by’ members of the public rather than ‘to,’ ‘about’ or ‘for’ them. And by public we mean patients, potential patients, carer’s and people who use health and social care services.

Our aim is to see a dynamic partnership between the public, researchers and others to advance all forms of research to improve the health and well being of the population. That partnership can manifest itself in many ways. But strategically i see our task at INVOLVE as very much to build relationships with other organisations in research – whether they be universities, our Medical Research Council (MRC) or the different programmes that make up NIHR.

We are composed of over 30 ‘members’ who comprise service users, carers, researchers, members of the public, clinicians, people from patients groups who are appointed every 3 years. Currently we have 4000 people on our mailing list, covering over 40 countries. We have a budget of £250k a year and I have sometimes heard it said – indeed I have said it myself – that we are not a delivery organisation in the sense of being at the front-line.

But actually we deliver a great deal.

Our task is to provide leadership on public involvement by supporting shared learning, to help build and share the evidence base through a network of people researching public involvement and by developing an online database of reports about the nature of public involvement and it’s impact, developing capacity and capability with briefing notes, guidance and our annual conference as well as other meetings, and influencing policy and practice not least by informing the discussions that happen within Government through our status as a government-funded body.

SUCCESS AND ACHIEVEMENTS

If I now look back over our history to when we were first established in 1996, I would point to several important factors behind our development as a body but also, I hope, our success and achievements to date. They are:

Partnership

Leadership

Continuity

The rise of citizenship

Impact

Given my previous remarks, you will not be surprised that partnership is the first of the factors I would point to. From our inception, the desire and ambition to develop a partnership between the public and researchers, has been the core philosophy which drives our work. It has enabled us to bring together very different perspectives and encourage discussion in a safe haven. This was particularly important at the very beginning when the environment was very hostile to what we wanted to do, it remains equally valued today.

It is also fundamental to how we must deliver. For two reason. First it would be arrogant to operate as if INVOLVE is public involvement in research. It would not only disenfranchise our community but also mean that we would miss out on the many stories out there that would influence and persuade others. Second, given our size and resources the reality is that we can only take forward our work through partnership with, and support for, many others at both a national and local level. That often requires diplomacy and consensus working that does not always please the most passionate advocates. But, done well and done transparently, I believe it leads to more durable outcomes.

Moving on, we have also been blessed with outstanding leadership at both a local have national level. These individuals – including my predecessors as Chair of INVOLVE and Derek Stewart who is speaking to you later – have been instrumental in ensuring that the public involvement message has been heard in the meetings and rooms where it matters, in pursuing the agenda despite all challenges put in their way. There is also no doubt that the commitment of key figures in research has also been pivotal in out progress, not least by our Chief Medical Officer and Director of R&D, Dame Sally Davies, who heads up the NIHR, but also her top team of programme directors. They have been growing and important voices in the room with whom we have been able to join forces.

The third factor is that when the National Institute for Health Research (NIHR) was established six years ago, it provided a roof and funding for INVOLVE. Such stability and strong foundations – together with the leadership I have just mentioned – are important to giving organisations such as ours the continuity and guarantee of life that enables them to pursue their objectives, free of other distractions that can deflect them from their mission and purpose. The risk of complacency with such a model is removed by the fact that our contract has to be renewed on a regular basis.

NIHR has also been crucial to the development of clinical research networks in the UK – some but not all condition specific – that provide an infrastructure for the advancement of clinical research, a strong framework around which we have been able to drape public involvement. But I shall let Derek tell you more about these.

The fourth factor is that there is no doubt that we have been as much shaped and assisted by external factors – particularly the rise of citizenship in debate and policy – as I would hope we have shaped them. Since the mid-nineties we have seen the passage of legislation that has enhanced the rights of people with disabilities, minorities and others; that have reflected a growing desire to put the patient at the heart of care and search. That has been matched by an industry of effort by those who commission and provide services to include the public in their shaping. Not to mention an agenda from within science – driven by a sense of vulnerability about its relevance to society particularly in austere times – to be seen to have the public very much in focus. These things have helped, there is no doubt. The challenge has been to ensure that they are not merely skin-deep.

The last factor has been our ability – particularly in recent years – to be able to demonstrate the impact of public involvement on the quality and relevance of research. Two years ago, INVOLVE published a report with NIHR which gathered examples of this impact and we intend to repeat the exercise again. But it’s very existence has certainly helped us to strongly counter the argument that is often presented to us by researches about the lack of evidence. That is changing but I can not help note with some irony that in the ongoing reform of health and social care as well as developments in science such as personalised medicine, the individual patient story, their experience and their desired outcomes is having growing credence.

THE TASK AHEAD – EVERYTHING HAS CHANGED, NOTHING HAS CHANGED

Looking ahead, what are the key challenges and opportunities facing INVOLVE and it’s partners?

Well, we have a saying in England – I am not sure what the equivalent here in Denmark is - which is that ‘nothing has changed and everything has changed.’ For, among our challenges and challengers, there are some old familiar faces. There are also old faces with new accents and feature. But there are also some significant new issues for us to deal with.

I hope the ones I have selected not only resonate with you but also hold some additional learning for us all about our path going forwards.

Perhaps our task ahead is best encapsulated with two pieces of evidence. The first is a paper published in 2007 by Rosemary Barber and colleagues – Rosemary is a member of INVOLVE – based on a survey of almost 1,000 health researchers. It showed that less than one fifth had involved the public in their work and that many of those surveyed were deeply apprehensive about public involvement on a number of scores. The second piece of evidence is from a report that INVOLVE published with the National Research Ethics Service (NRES) at the end of last year. This examined the extent to which public involvement featured in research grant applications coming before ethics committees. It then looked at the funder of each of these.

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!

So our main challenge continues to be individual and institutional attitudes if not outright resistance to public involvement. There is no magic bullet here. Clearly there is much we can do to train young researchers and nurture a grassroots movement within our universities and elsewhere. But what we really need is much greater organisational leadership among research funders in particular. For instance, less than half of the medical research charities in the UK – who pride themselves on funding quality and excellence in science using public donations – involve the public in the governance of this research in any form whatsoever. This must change.

The second challenge also presents opportunities in my view. As you may be aware, we have recently seen legislation pass through our parliament which will mean wholesale change for the way in which health and social care is commissioned and provided. The Government’s stated objective since the reforms were first announced is to put patients at the heart of these changes with its mantra of ‘No decision about us without us.’

These reforms – whatever the commentary about them as a whole – actually represent a major opportunity for the advancement of health research through our National Health Service (NHS) and for public involvement. The legislation includes new duties on all parts of our health service system to promote and advance research. The absence of such duties up until now – in spite of the fact that research has supposedly been a core mission of the NHS – has meant that our hospitals and doctors have often neatly tucked research in their inside pocket rather than worn it on their sleeve, our of sight and out of the way of patients and the public except by invitation only.

This new challenge on the NHS actually means that patients have every right, with the appropriate tools and evidence, to go to their clinician and ask to be considered for a clinical trial or other piece of research. From this greater engagement and participation of patients, further involvement in the way that research is conducted will spring, research that is of greater relevance to their care and the quality of heir lives. I think that it also provides an opportunity to forge stronger alliances with our colleagues across the provision of care services to develop a wider social movement for change.

This goal of greater engagement and participation of patients is a new strategic priority for the NHS and one that I have been asked to take on as the National Director of Public Participation and Engagement in Research. As I often say, if we we want willing patients we also need willing leaders and a willing NHS to make it happen.

Not all think so. In fact many of my friends and colleagues think that there is a hidden agenda here that goes against the grain of what we have achieved already. I completely understand this although I do not agree. My argument would be that surely ever greater engagement and participation has to be the goal of any democratic endeavour. Also, that introducing concepts such as democracy and citizenship into research, is not purely about improving the process , but also about the delivery of improvements in health and well being. Otherwise we are in danger of modelling the behaviour of those we criticise who seem only interested in the scientific pursuit itself.

So I do worry somewhat the third challenge is self-imposed, that we are ourselves our own worst enemies, obsessed with definitions, almost puritanical about what does or does not constitute involvement, in danger of creating an academic pursuit alone, rather than remaining externally focused and dogged in our pursuit of what matters to the public and patients. I am not saying that these things are not important but we must be careful that they do not dominate matters to the exclusion of what we all came into public involvement to do.

Finally, a footnote but an important one, and this is that we live in times of deep austerity as you know. We are fortunate in having strong foundations but it is vital that we do not become detached from our grassroots and their experience where things are extremely difficult. For this is where our strengths lie and, if we are to build a real movement for change, then it must come from the ground upwards as much as anywhere else.

AMBITIONS

To conclude, let me share some ambitions for the future.

I recently did a video interview for The Guardian newspaper. One of these ‘five minutes with..’ where they ask you some serious questions but also some not so serious ones about the things that make you smile or keep you awake at night. I am not sure whether it is up yet but you might not recognise me as I was sporting a beard and had longer hair – much to my mother’s irritation.

Anyway, they asked me what I would like to see change in healthcare over the next five years. And this is what I said:

First, to see our National Health Service wear what it does in the name of research on its sleeve instead of hidden inside it’s inside pocket as I have said. This means every one of our hospitals being clear that it is ‘open for business’ for patients to come through their doors and to be offered the chance to participate on a clinical trials etc.

Second that every patient and their loved one sees taking part in research as part of their NHS entitlement, that they have the access to the information and tools which enable them to talk to their clinician and demand to be considered if necessary, to be able to make proactive choices about research in the same way that we aspire to enable them to do so in their healthcare.

Third, that all funders who fund clinical research conducted in the NHS can only do so if they are able to demonstrate a commitment to public involvement in how they determine their research strategy, set their research priorities etc

But I would add to that the need for us to take much more seriously the ‘respect and dignity’ aspects of people’s participation in research. That, as participants, they deserve certain things in return not least better information and feedback at the end of a trial.

And finally, it is for citizens across Europe to be working much more closely together in the name of public involvement in research. That is why afternoon’s such as this are important. Similar discussions are happening in many countries across the EU and the UK has much to learn from you and others as it can impart knowledge based on its own experience. Clearly many patient organisations have their own European groups and of course some patients/research ones exist although the agenda seems to be more about lobbying and education and information than changing the way things are done.

But it would be wonderful for patients, the public and indeed research if in five years time we were celebrating the coming together of our insight and passion in a European association which is for and about patients and the public in research. I look forward to seeing you then if not before and would like to thank you very much for listening to me.

Tak!

May 7, 2012

DH and charities reach acoRD over medical research costs ^Reply

acoRD, AMRC, Association of Medical Research Charities, clinical research, clinical trial costs, clinical trials, medical research, medical research charities, NIHR • Tags: acoRD, AMRC, Business, Charitable organization, Clinical trial, Department of Health, medical research, National Health Service, NHS

Divvying up the costs of conducting research in the NHS funded by medical research charities is an intricate business. Who pays for that research nurse, their time in administering the extra treatment required in a clinical trial, the procedures and equipment needed as part of its conduct, the oversight and governance needed to ensure that things are done properly and with patient care uppermost in mind? When do these costs begin and end?

For both the NHS and charities the concern is to be able to demonstrate appropriate use of respective taxpayer or donor funds, for the purpose for which it has been intended; to have a system for the apportionment of costs which recognises the value and contribution of both partners to making trials happen and does not inadvertently disincentivise either because of perceived unfairness.

It is an issue which has been tussled over for a considerable period of time with the latest discussions dating back to well before I left the Association of Medical Research Charities (AMRC).

Happily the Department of Health and AMRC have now reached agreement and the final document – entitled AcoRD for short – can be found on the Department’s website. The document – which came out late on Friday - takes a principle-based approach and includes case studies to guide decision-makers.

It is an important document. Consistent and coherent implementation overseen by both will be crucial. The linkage of the application of the rules so firmly to those charities who have AMRC membership, is an important amplification of the status AMRC now holds in ensuring quality and excellence in the sector.

April 19, 2012

The public interest argument must extend beyond open access…here’s a sort of lay summary ³

medical research • Tags: Alice Bell, AMRC, Earth Sciences, journal, Open Access, Patients Participate!, Paywall, Public Understanding of Science, publish, Scientific journal, The Guardian, Times, Wellcome Trust

Good Guardian blog yesterday giving a lay summary of the ‘open access’ debate vis a vis papers published in scientific journals. There’s also been a healthy exchange of letters in The Times this week but ironically that’s behind their paywall. However, at least The Times is available in all good newsagents at a reasonable price.

Unsurprisingly, I totally get and support the arguments in favour of open access. But inveterate blogger and public engagement in science expert, Alice Bell (blog home page here), twittered this morning that open access is more than just about publishing papers. Hear, hear!

I believe the arguments being made by research funders and others, that ‘open access’ has societal benefits, are sincerely held. But, at the same time, the debate does sometimes come across like a power struggle between the mighty and the mighty.

How good, indeed seismic would it be, were funders to use the same public interest arguments to ensure that the people they fund got their act together, not just about where they disseminate their research but how they disseminate it.

Public understanding of science will be marginally improved by better access to articles. Yet, it could be radically improved if we also saw a commitment to the writing of a good lay summary of their work and to see this appear with every published article. For some reason, funders have seemed reluctant to pay serious attention to this as an important tool to understanding science, its dissemination and impact. But it’s clearly in the public interest.

See the PatientsParticipate project for more.

Got to dash!

March 30, 2012

Clinical trials discussion – The Guardian ^Reply

medical research • Tags: AMRC, clinical trials, Jonathan Sheffield, Peter Weissberg, The Guardian

There was an online discussion hosted by The Guardian this morning about commercially sponsored clinical trials in the NHS. You can get the jist here.

March 15, 2012

Have charities really put the brakes on public involvement in research? ^Reply

medical research • Tags: AMRC, amrc peer review audit, Association of Medical Research Charities, Charitable organization, medical research, National Institute for Health Research, NIHR, NRES, research

I was pulled-over by the police on the M25 on Sunday night. Unbeknown to me, my car brake lights had failed so that they were permanently on. Quite apart from blinding any traffic on my tail, an unwitting driver could easily have mis-read my intentions with who knows what consequences. Thankfully that didn’t happen. And by the way, thanks to the AA man who repaired them.

A few weeks ago, the Association of Medical Research Charities (AMRC) published an excellent report of the five-year audit they have done of the Association’s 125 members and their peer review practices. You can download it from their website here. It shows that UK medical research charities are as committed as ever to independent external review of their science. And it is this sector-wide commitment to peer review – to almost the exclusion of all other factors – which locks them into the prevailing consensus on the pursuit of science in the UK. For better of for worse.

But there is a statistic in the report that troubles. This shows that the number of charities that use lay people in peer review (49%) is very similar in 2011/12 to that (53%) of the previous previous audit completed in 2006/7. Have charities really become static on public involvement or am I just not seeing through the static?

Now, we have to be a bit careful here because I know from colleagues that the story behind the numbers today is quite different to what it was then. Five years ago charities tended to simply stick lay people on panels, count this as involvement and forget about them. Nowadays – as AMRC’s report and other documents it has produced shows – the role and contribution of lay people is better facilitated and richer as a result, from separate panels feeding into peer review, to developing research strategy not to mention contributing to research dissemination. AMRC’s science communication awards also bear witness to this.

But I am not going to let my beloved sector off the hook completely: there are other indicators that paint charities in a disappointing light when it comes to public involvement. For, even with the silver lining portrayed above, the figures in successive AMRC peer review audits indicate that around half of medical research charities do not involve the public in the way they decide how to apportion donor or supporter money to research. Go figure.

The recent INVOLVE/National Research Ethics Service (NRES) report on public involvement in grant applications also showed that, of those funded by charities, about one third included no public involvement and about another third had ‘ticked’ various public involvement activities as part of their study but were unable to confirm what this was in free text. In my view charities should be at the top of the leader board, way ahead of the current front-runner in the INVOLVE/NRES study which is the National Institute for Health Research (NIHR).

I also know from my work with NIHR’s clinical research networks – and local research networks in particular – that charities are certainly ready and eager to fund clinical trials or studies. But they can be less engaged in the equally vital task of securing patient and public involvement in trials, and in recruiting patients when trials open.

This whole area deserves deeper inquiry to find out what the true story is. But my hunch is that a core of charities, enlightened about their relationship with their public, have simply got even better at the task of involvement. Too many, however, continue to tiptoe nervously around the subject. Others just refuse to play ball for one uncharitable reason or another. This does science and the public a disservice.

With ever greater scrutiny of their role in society, charities must constantly demonstrate and not just advertise their unique ‘copyright’ over public support for research in this country. By involving their beneficiaries they can perform an important pseudo-regulatory role in ensuring that the way in which science is conducted – as well as what it chooses to focus on – ‘protects and promotes the public interest.’ Their supporters prove time and time again to be the best at getting the message across to fellow patients, clinicans and researchers. But most of all public involvement is a fundamental part of the charity genome: it is the impulse that urges us forward to question, to innovate, to never accept the consensus.

Don’t get me wrong, I think the charity sector is one of our greatest strengths in UK health research. That doesn’t mean though that on some things I don’t think we can do better, much better.

But perhaps I just can’t see past those faulty brake lights.

March 2, 2012

It’s a rare day when nothing happens…. ¹

medical research • Tags: AMRC, Awareness Weeks, Birdshot Day, Birdshot Uveitis Society, rare diseases day, Rare Diseases UK

Without wishing to open that old hornet’s nest about the value of Awareness Days/Weeks/Years [delete as necessary], it does seem as though February and March are the busiest months for such events doesn’t it? Tweets announcing the latest and the greatest pop up on my phone like the offspring of rampant sheep, such are their regularity.

Are there enough days left for awareness, I wonder? I am sure there is some bright PR guru out there, advising an ill-advised organisation to break the mould and hold a ‘non-awareness day’ – just to be different. Since most awareness days appear to be national in their intent, I am myself thinking of starting ‘micro-awareness days’ exclusively within my own home. These will draw household attention to key issues such as room cleaniness, tv-remote rage, and the case for re-homing odd socks.

In spite of this seemingly unkindly introduction, I tend towards the view that there is space for them all and that the best really can be quite brilliant.

Earlier this week it was rare disease day 2012. See here for more info about the Rare Disease UK national alliances which has had a not insignificant impact on policy in the short time since it has been around: cue link to the plan for rare diseases published this week by the Department for Health and open for consultation.

By coincidence, I am speaking tomorrow at the Birdshot Uveitis Society’s ‘Birdshot Day’ in London. Birdshot Uveitis is a rare disease which leads to sight impairment and, more often than not, blindness. Tomorrow, patients and professionals will be coming together to launch and celebrate the establishment of their new research network and biobank. An incredible achievement in the less than two years since Rea, one of their founders, came to see me at AMRC to discuss their vision and plans. And this, before they had even registered as a charity.

It will be a brilliant day.

February 8, 2012

The duty falls on all of us to issue that wake-up call to the NHS about its research mission ^Reply

medical research • Tags: AMRC, Becky's Policy Pages, Bill, clinical research, clinical trials, Health and Social Care, Health and Social Care Bill 2011, INVOLVE, medical research, medical research charities, National Health Service, NHS, NIHR, NIHR National Director for Public Participation and Engagement in Research, Social Care Bill

Last week, medical research charities among others hailed a series of Government amendments made to the Health and Social Care Bill. These place ‘a strong duty across the Secretary of State, the NHS Commissioning Board and Clinical Commissioning Groups to promote research and the use of research evidence.’

The amendments are in response to persistent lobbying; their underpinning arguments can be traced back many years, far beyond the initial responses to the Health White Paper in 2011 which presaged the publication of the Bill.

The need for them is pressing.

Yesterday, INVOLVE held an all-day ‘Introduction’ for our newest members. A number have emerging roles in the new Clinical Commissioning Groups (CCGs) in their area. The anecdotal evidence from these colleagues is that the vast majority of CCGs are not switched on to their role vis a vis health research whatsoever. In fact, it’s not just that they are not switched on, but that they are not even ‘wired’ in ways which will ensure they engage with this agenda on anything but the most basic level. That’s not good for those of us who see them as playing a crucial role in ensuring patients are supported take part in research. That’s why the legislative changes can help.

However, reflecting upon this last night, I couldn’t help but conclude that writing a new duty into law for the Secretary of State and others, only underlines the duty on all of us to make its intent a reality.

The simple days of command-and-control, of upward delegation, in making things happen in the NHS in a linear fashion are long gone as you know. The delivery of health and social care is now more diffuse than ever before. It is inherently more complex than commonly perceived (a perception amplified in popular tv shows harking back to a time long gone such as ‘Call the Midwife’).

We have to be smarter and cleverer and more creative to help engineer the change in culture we so desire. Not least in ensuring that ‘the system’ if I can use that term, does its level best to engage with, and ensure, patients can participation in research at whatever point they enter it.

It means paying more than a little attention to shaping the ‘demand-side’ of the equation or, if you prefer, to the application of theories about change management. Regardless, the bottom line is that it means empowering patients to approach their doctor, their practice nurse, a member of staff, about research.

Pushing this change through will have many elements to it. They will need to be pursued over a considerable period of time. Making sure NHS organisations and others uphold their duties is only one aspect.

In fact I would hazard a suggestion. It is going to be as much down to organisations who have successfully lobbied for the amendments mentioned above, shining a light and applying external pressure which wakes the system up. And part of that will involve them taking steps to empower their patients and supporters appropriately.

I’m looking forward to working with these and other partners inside and outside the NHS in my new role as NIHR National Director for Public Participation and Engagement in Research

We have a great opportunity, better than we have ever had before, to ensure the NHS lives up to its ‘research mission’ as people once used to call it. But our starting point must be that the duty falls on all of us to make sure this happens.

January 20, 2012

Charities wade in on Leveson and media reporting of science ^Reply

medical research • Tags: AMRC, Association of Medical Research Charities, Cancer Research UK, Leveson Inquiry, Mass media, Media, medical research, Wellcome Trust

The Association of Medical Research Charities (AMRC) together with Cancer Research UK and Wellcome Trust have this afternoon published their response to the Leveson inquiry into the culture, practice and ethics of the press. See first item listed under 2012 on this page at the AMRC website.

The submission makes good points and I learnt a thing or two about how practices and approaches to science reporting are changing. Note the reference in it to The Guardian for instance.

Of course, today we have a real-live case study in the media with the news of the Human Fertilisation and Embryo Authority’s (HFEA) public consultation on the acceptability of new techniques to treat mitochondiral disease and the associated Wellcome Trust £4.4 million grant to Newcastle University to build a new centre to lead research in this area.

My sense is that media reporting of this sort of ‘high-politics’ event in science seems to have improved and is continuing to improve.

The more difficult issue is the daily churn of lower-lying misinformation in the media about science or more specifically health research and associated health claims on which people may act. That seems a somewhat harder nut to crack. Some of the proposals made by AMRC et al would help. But there are wider issues around training etc that could also have a positive impact.

Anyway, I am pleased that they’ve done this and brought this to the attention of an inquiry whose recommendations will have a long-lasting impact on the culture and practices of the press.

January 17, 2012

[The definite article] and why it stands in the way of a definitive plan for UK science ^Reply

medical research • Tags: AMRC, Campaign for Science and Engineering, David Cooksey, David Willett, government, Policy Research Centre, Royal Society, Russell Group, spending review

****you might also like to read William Cullerne Bown’s analysis of the Science Minister’s speech referred to in this blog and which appeared on the same day as that below***

Yesterday the Royal Society posted on its website the full text of Lord Rees’ Christmas Lecture to the Science and Policy Research Centre. Its worth a read for its very grounded comments about the role of scientific advisers and scientific advice in Government, and why scientific evidence can’t reign supreme in a policy or political context.

It is the sort of grounding I was in need of, after a day – thoroughly absorbing I hasten to add, attending an expert seminar of the Administrative Data Taskforce. This is the group set up under the Government’s plan for economic growth to look at how data sets held by different Government departments could and should be linked in the public interest. Inevitably, I found myself in the sub-group looking at public engagement. It’s an occupational hazard I am afraid.

The public. Now there’s a thing.

Or should I say [the definite article] public. For, funny how easily public engagement work can become stymied by a desire of its architects to, first, make a pre-emptive strike on the definite article.

We must pin ‘the’ public down before we ask them. We must know who they are. We must see the whites of their eyes. As if they were somehow an elusive enemy that we need to label to make sense of our own insecurity and fit our academicness. On the other hand we could engage – talk, listen and learn – first, and then begin to design our future discourse with ‘the public.’

I digress.

Lord Rees and, indeed, the definite article, came to mind as I tonight pondered the reaction to the Science Minister, David Willett’s, recent speech in which he said he wanted to make the UK ‘the best place in the world to do science.’ He also ventured a few ideas such as a new science university funded by business and those with lots of money.

I say ‘reaction’ because apart from one or two very thoughtful pieces – especially this by Richard Jones , a rapid response by the Campaign for Science and Engineering, and the Russell Group‘s pre-emptive declaration the day before that it had set up a special group to look at business and industry collaboration (you mean they didn’t have one before, go figure?), comment from around the world of science has been somewhat lacking and certainly not unified. Well, apart from people saying they were still looking for Government to express ‘the vision.’

Lord Rees came to mind because I recall attending a meeting chaired by him in the days after the Spending Review announcement. The relief of the great and good in the room was palpable. But it was the sort of relief expressed by someone who has had a bank loan approved, not that which is about getting the go-ahead to shoot for the moon. The forensic disassembling of the announcement there and then by many, was prescient given what we now know about the funding picture.

Nonetheless, it was agreed by all that unity had been vital - Science is Vital - to getting a better than expected result from Government and that this unity needed to be solidly maintained behind a shared vision. Willetts has also said so himself on many occasions since.

In pondering today’s unfolding picture I wonder whether the science community is now on the verge of failing itself and its Minister, of losing the momentum of the Spending Review campaign. It certainly does not seem to have moved on from those days. Yes, the concerns over funding, impact and other issues are heartfelt and significant. But, without care, the near-term view of these matters is potentially energy-sapping for all concerned; they distract from the bigger task of setting out where we want to be.

In my view, it seems to want to pin Willetts down until he has served up the definite article in a palatable form, rather than serving up its own comprehensive plan, in a unified manner and with a strong lobby behind it. At the moment one perceives a lack of coherence and more than a hint of parochialism, or worse still, of it being just a little non-plussed by events and having gone to ground. And for all these reasons I have some sympathy for the Minister.

Shortly after I became Chief Executive at AMRC in early 2006, David Cooksey published his review of health research. Eager to impress and make a mark, I banged out a news release with the usual words of welcome while highlighting what I thought was the most important aspect. Let’s just say it wasn’t quite like any other people’s releases.

The day after the announcement a few CEOs of shall we say the more well-known medical research charities rang me to advise me from firing from the hip. Although I took umbrage at the time, I now understand why they did. It wasn’t what I said that mattered, so much as the appearance it gave that we were not singing from the same hymn sheet. More over that the vision and its acceptance and articulation by the Government had been hard-fought for and not to be lost cheaply. The legacy of that can be seen in the strengthening of NIHR, the funding of health research and the life sciences announcement before Christmas.

I am one step removed from the science debate now, so who am I to comment? But science needs to up its game if it really is serious about ‘the vision’ for UK science. Only then will we see the definitive document.

January 8, 2012

Research is for life: making research part and parcel of the patient journey ¹

INVOLVE, medical research, PatientLikeMe, Public attitudes to science survey 2011, public engagement, public involvement • Tags: Alzheimer's Research UK, AMRC, Brin Helliwell, charity funding for research, Christmas, clinical research, David Cameron, David Willetts, Furlong Christmas Lecture, Georgia, Georgia Semple, Health and Social Care Bill, INVOLVE, James Lind Alliance, JLA, liberation therapy, life sciences package, MCRN, medical records, Medicines for children research network, MS Society, National Institute for Health Research, NIHR, Orthopaedic Research UK, Patient, patient data, public involvement in research, research, research citizen, research patient, Ronald Furlong, Science Minister, Your health records save lives

I was very privileged to be asked to give the Furlong Christmas Lecture a few weeks ago. I hope this doesn’t seem egotistical but here’s the text of that lecture amended with useful links etc – it touches on and rehearses themes that will be familiar to those of you who have visited the blog before. Nonetheless I hope it makes for an interesting read and perhaps sparks some thoughts of your own.

The Furlong Christmas Lecture – 2011

Good evening ladies and gentleman. May I begin by saying what a great pleasure to be with you.

I feel very honoured indeed to have been asked to give this, the fourth Furlong Christmas Lecture. Ronald Furlong left a rich legacy in research as you know. He was also quite clearly a force to be reckoned with. By all accounts, his pursuit of innovation that would improve the lives of his patients was formidable; his concern that the patient should come first, courageous. I read a comment by one of his long-standing friends that such was his size one could not see the door once he had stepped through it. I know I certainly would have wanted him on my side as a patient.

Ronald Furlong’s philosophy lives on, of course, in the work of Orthopaedic Research UK. The desire to put the patient first is self-evident in everything I have read about the charity, its work and its history and I would like to take this opportunity to congratulate it on another successful year. The fact that increasing numbers of researchers are applying for your funding is a clear signal of your credibility and growing stature in the scientific community.

Putting patients first is also the theme of my lecture tonight. But, unlike my predecessors, each of them scientific leaders in their own right who have lectured on key developments in their field and what they might mean for patients, I am going to take a different approach.

I hope to examine and explore with you how patients are actually putting research first in their lives making it part and parcel of their patient journey. Also, how we might widen public involvement and participation in research to ensure that we make the most of opportunities that will mean better outcomes for patients in the future and enhance our international standing and reputation for cutting edge research.

Perhaps I should say at this point that there is an intense, and intensely, fascinating debate about the relationship between science in general and wider society. Much as it was tempting not too, I have, however, elected to focus my thoughts primarily on medical research and clinical research in particular as it seemed most likely to resonate with you.

As Chair of INVOLVE it is also important that I explain from the outset that our definition of public involvement is of a wide spectrum of activities which extends from public engagement thru participation to, most importantly, active involvement in research decision-making.
If nothing else this evening, I hope you feel that what I am about to say is timely and topical given the Prime Minister’s speech earlier this week setting out the Coalition Government’s ambition on life sciences and their aim of enabling everyone to become a ‘research patient.’

Pioneers

Let me begin by introducing you to two people whose stories can help I think, illustrate what I mean by public involvement in research but which also encapsulates how far we have reached in the UK in terms of its achievement.

The first is a young lady featured in the rather grandly named ‘Wirral Globe’ just a few weeks ago. Georgia Semple is 14 years old and was diagnosed with Leukaemia when she was 9. She is a member of the Young Person’s Advisory Group for the National Institute for Health Research (NIHR) Medicines for Children Research Network – one of a number of such networks established in the UK in the last five years to promote and advance clinical research.

As well as doing all the things that young teenagers like to do, Georgia also helps researchers design child-friendly clinical trials and develop medicines information that children can understand. Her role has taken her to parliament as a research ambassador and, in her own words, she says: “I really enjoy my work with MCRN because what we are doing will help young people understand more about medicines, research, and improve treatments for young people in the future.”

The second person is Brin Helliwell. Brin is a school teacher who was left partially paralysed by a stroke in 2005. His pursuit of recovery and wellbeing since then has led him to participate in a number of clinical studies. Asked by researchers and fellow patients to develop a tool to encourage others to do the same, he proposed a video project which is now on the main website for the NIHR Clinical Research Co-ordinating Centre in the UK. Quite rightly, as executive producer, he takes the starring role in the first of the videos produced and now available on their website. Here he is in his own words.

The point about Georgia and Brin and indeed initiatives such as this at the University of Bristol School of Clinical Sciences, is that they are still very much pioneers in the move to see people much more involved in the decision making activities in research projects and in research organisations.

As pioneers they are leading from the front, highly self-motivated, challenging attitudes and pushing at the frontiers. My sense is that Ronald Furlong would therefore have felt a great deal of affinity, and would have been delighted to share this stand, with them. He would have also, I am sure, empathised with their sense of isolation as frontiersmen and frontierswomen and of the steely nerve that they would have required to get this far in settling new and sometimes hostile territory.

It is also the explorer’s burden to tend to have your actions considered with a mixture of awe and consternation by your fellow human beings.
For the fact is, the common perception of how patients and the public engage with and contribute to research is far removed from what Georgia, Brin and others do. It is to see the public as a force to be mobilised to raise funds for, or influence opinion in favour of, research – often motivated and led by the relevant medical research charity concerned.

Let me give you a brief example from my own experience but one I believe we can all relate to.

Mrs Sharp – not her real name – is a middle-aged women who stands outside my local Tesco Express collecting money for Alzheimer’s Research UK. As well as caring for her mother who has dementia, Mrs Sharp turns come rain or shine to fundraise with a small and rather battered collection tin. Last time I spoke to her she gave me a copy of the letter she had received from the charity thanking her for the £3,000 she had raised. And for me she has become rather symbolic of this common and traditional perception of the role of the public when it comes to research.
As you can tell I am a big fan of Mrs Sharp.

But, my issue with seeing Mrs Sharp as the be all and end all of the relationship between research and the public is not that it is wrong. Not at all. Yet it lacks a sense of ambition. Indeed by defining public activity in this way we limit our horizons as to what patients and researchers might achieve together if they see each other as part of the same community working with common cause.

Before considering this partnership further, it might be worthwhile to pause for a while and reflect on the role of medical research charities in the UK. Because they can also tell us a lot about the relationship between research and its public.

Charities and medical research

It is my view that the contribution of charities to UK medical and health research continues to be understated if not underrated. It certainly was by the Prime Minister and his Ministers this week who barely mentioned them.

Charities as represented by the 120 plus strong membership of the Association of Medical Research Charities (AMRC) collectively raise and fund approximately £1.3 billion of research in the UK every year. That figure is double what it was just over six years ago. Charities now represent over one-third of all publicly funded expenditure of research here in the United Kingdom, a situation that is unparalleled anywhere else in the world.
Given that the majority of these funds are raised from the British public – about £2,500 a minute – charities are I believe an important symbol of the public’s interest in research.

Indeed they are a good counterpoint to the argument that the public are semi-detached from research. Medical research is the leading charitable cause to which people give (in spite of a recession) in the UK. Only the Netherlands has a higher percentage of its population raising money for research. These two facts alone are helpful in building a case that not only do the public ‘get it’ but that they also ‘raise it’ by the bucket load. All the evidence is that they see a donation to research as having immense value and potentially making a highly tangible difference.

The other deliberate reason for pausing on charities for a moment is to ask you to consider one other important factor for their rise and which is relevant to the theme of my talk. The growth in charities as research funders but also their assertiveness on key debates in science – from hybrid embryo research to the current Health and Social Care Bill going through parliament – has primarily been driven by those charities which are in turn driven by a strong and active patient group or patient constituency by their side, knowledgeable not just about their condition or that of a loved-one but also about the research that is important to it.

We have evidence of a research-sympathetic culture. The real question for me therefore becomes how we turn what patients and the public currently do – which is valuable and important in its own right – into something more? Perhaps, you might ask, why should we?
Well, there are three principal reasons in my view.

Why public involvement in research matters?

The first is what I call the mission argument –and takes its calling from the assertion by Dame Sally Davies, Chief Medical Officer and Head of the NIHR, that a hallmark of a modern healthcare system is its capacity and capability to advance science knowledge and understanding, develop new treatments, therapies and intervention and incorporate these into policy and practice.

None of this endeavour can happen without the inclusion of patients and certainly not in a universal health care system where the mantra is now ‘Nothing about us without us.’ It would be a little like a high street retailer opening-up shop without taking any heed of its potential consumers nor listening to their comments and feedback or indeed looking at their own sales on a day-to-day basis. I think the last person who tried something like this was Reginald Perrin and looked what happened to him.

The second is what one might call the bottom-line argument or the ‘Charge of the Light Brigade’ argument if you prefer the Science Minister, David Willett’s analysis. As the Coalition Government expressed this week, there is an economic imperative to strengthen and improve research and innovation here in the UK; not just to drive greater efficiency in our healthcare system but also to maintain and strengthening our international standing as a leader in clinical research.

The most common evidence or statistics cited by commentators to suggest that this position is under some stress is to look at the UK’s share of clinical trials compared to other countries – down from 6% to 2% is the most oft-quoted figure. Monday’s announcement on life sciences builds on the work of the last five years builds to rectify this position with better infrastructure and greater funding. And we are most certainly moving in the right direction – more than half a million people participated in studies supported by the NIHR Clinical Research Network in 2010, a 24% increase on last year. But this effort will be for nothing unless we focus even greater attention on empowering patients to come forward to participate and become involved in clinical trials and studies.

The third reason is the ‘evidence-base.’ The fact is, there is now increasing evidence that involving the public in research can improve its design, its conduct and its outcomes. Two years ago INVOLVE together with NIHR published this document which collected together case histories of the way in which public involvement had a beneficial impact. I am going to mention one of them but start by drawing your attention to an example recently featured in The Guardian.

I am sure that a number of you have heard of the James Lind Alliance (JLA) – named after the Scottish naval surgeon James Lind who pioneered clinical trials 250 years ago. One of the key activities of JLA – funded by NIHR and the Medical Research Council (MRC) is what are termed ‘Priority-setting partnerships’ the aim of which is to identify the key research questions that matter most to patients and clinicians, that if answered, would improve the quality of patent’s lives.

In the example covered by the Guardian which took place in stroke medicine, clinicians, patients and researchers whittled down 500 possible questions to just 10 which can now be used as the basis for future work, funding and inquiry. Similar exercises have been done in asthma and prostate cancer with very promising results in directing future lines of inquiry.

Turning back to the INVOLVE publication, the example I wanted to mention is also from prostate cancer. In this instance, researchers faced real difficulties in recruitment to a prostate cancer trial so they decided to carry out some in-depth interviews with potential participants to understand why they were not coming forwards. What emerged from the interviews was that not only were researchers not explaining the research clearly enough, but that to all intents and purposes some of the terminology used was being misunderstand in ways that actively turned people off. So when researchers used the term ‘watchful waiting’ to describe the non-treatment aim of the trial, patients interpreted this as if clinicians would, I quote: watch while I die.’

Oh dear.

Changing this term to ‘actively monitoring’ and making a number of other tweaks gave patients more confidence and, as a result of some of these simple changes, recruitment rates went up from 40 to 70 per cent.

But in addition to these three reasons I believe there is another pressing argument in favour of increasing public involvement in research. For it can help us collectively manage some of the new tensions that are arising out of an increasingly exercised and democratised public. I think we must be acutely aware that in the external environment around us the public is rightly feeling more willing and more confident about challenging traditional boundaries. This growing desire to assert one’s citizenship becomes particularly passionate and more energetic when it comes to people’s own health. And research is not immune to it.

Managing tensions

I thought there was an interesting illustration from Canada this summer of this tension and what it can mean. It concerns ‘Liberation therapy’ as a potential treatment for Multiple Sclerosis.

As you may be aware, Liberation therapy was ‘discovered’ by an Italian scientist called Dr Paolo Zamboni in 2008. The theory goes that by widening supposedly blocked neck veins one drains blood and iron deposits in the brain, thereby alleviating MS symptoms. It is highly controversial with many, many scientists disputing Dr Zamboni’s methods and its impact.

But the clamour from MS sufferers, their families and the national and local media in Canada for patients to have access to ‘liberation therapy’ was overwhelming. Some patients travelled abroad to the United States to get the treatment. Some of those who took this route died. From day one the Government and scientific community was very much on the back foot and seemed ill-equipped to deal with such a public controversy. However, to its credit the Government did the only thing it could in the circumstances. It set up a working group to review the latest research and make its recommendations, and concluded with a decision to proceed with a call for Phase 1 and 2 clinical trials.

Is this story a case of ‘power to the people’ usurping science and the scientific process? If the Government had caved in and had gone a different route to its decision to conduct an expert review and base its actions on this, then perhaps the answer might have been ‘yes.’ Nonetheless, it is an absorbing case study in how any Government can come under extraordinary public pressure in the field of medical research and treatment.

In considering whether what happened in Canada could happen in the UK, you might wish to note the following as factors that would mitigate if not prevent the same event. Most important of all, Canada’s record on public involvement is not good. Only very recently have they regarded it as a strategic priority. By comparison, and despite the fact that public involvement is still emergent here, our own equivalent of the Canadian Institutes, NIHR, has an established and funded programme in INVOLVE, and it has made public involvement a requirement of NIHR grant funding as well as a strategic priority for those whose lead and manage its various activities.

Also, although the controversy did indeed cross the Atlantic it only lapped rather than broke our shores. I have no doubt that a fundamental reason for this was the way that the MS Society and MS Trust – the leading charities here in the UK – managed the debate by being open and transparent. Not only were they frank in explaining their standpoint but they also used social media and social networking sites as forums where patients in favour, or those against, could debate and discuss the pros and cons.

I wrote on my blog fairly recently that this approach of seeing patients as partners in managing an issue and expectations is absolutely fundamental if science and scientists are to avoid a clamour for liberation some way down the line. It has also been significant in making the relationship with our own regulatory agencies here in the UK such as NICE are less stormy one than it might have been.

Social media

Another ‘new’ tension – which I have already referred to in passing – is the challenge arising out of people’s use of social media and technology to set their own agenda in research.

This is much more developed in the United States and some of you may have heard of this site called ‘PatientsLikeMe’ which thousands of patients are now joining to share knowledge and experiences of their respective conditions. Researchers and pharmaceutical countries are increasingly keen to tap into it as a mine of data as you can imagine. And PatientsLikeMe have already formed a number of partnerships with research organisations can engage with its users as a ready pool of participants in research.

In the United Kingdom we have only seen a slight stirring of such activity, with the most developed examples occurring where there is quite a cohesive and organised patient grop.. But I myself been approached by several other individuals already this year about setting up similar, more generic sites and I have no doubt that this trend will accelerate.

Whether you see this as patients taking the law into their own hands or trying to make sense of their experience for the wider good depends on your standpoint. As you’d expect, my perspective is that this is a natural occurrence borne out of the latter and which, if harnessed, could be enormously powerful.

Unfortunately, and rather unfathomably, our systems and institutions here in the UK seem unable to grapple with the enormity of it. I wonder whether the root cause of this is the considerable cultural difference that exists between researchers who view social media in a very utilitarian sense (as another information provider), or the doctor who understandably worries about patient confidentiality, and the many members of the general public who increasingly see it as a way of life and are comfortable with forming networks and sharing information with friends and strangers.

Did you know, for instance, that the average mobile phone user is never more than three feet from their phone? – That’s a comforting three feet nearer than a rat if you live in London. Or that 1 in 3 people say that they could not live without the internet.
We need to, get with the programme, as they say.

Overcoming the barriers to public involvement

So, thus far this evening, I have talked about the current state of play in public involvement, the role played by charities and the opportunity their engagement with the public represents, the reasons why public involvement is important in our future endeavours in research, and some of the new tensions in health arising out of a democratized public where public involvement is and will be invaluable.

In this last portion of my talk I’d like to touch upon how we can overcome the barriers that stand in our way to public involvement and to patients seeing research as part and parcel of their patient journey. I’d also like to address that notion of the ‘research patient’ as David Cameron put it.

The most difficult barrier to overcome in my view is in terms of the knowledge, understanding and acceptance of public involvement among researchers. And, in my opinion, it is often the funders and the institution and their leadership which has the biggest role to play in shaping their viewpoint.

Two weeks ago, INVOLVE and the National Research Ethics Service (NRES) – now part of the new Health Research Authority (HRA) – published an interesting study of the public involvement component of grant applications put before NRES. It showed that less than 20% of researchers had responded with plans to involve the public, 43% of researchers misunderstood what they were being asked, and 38% said they had no plans for public involvement. I find that quite alarming in the clinical research arena.

Even more telling was the variation in these statistics between those researchers being funded by NIHR (who were the most well-versed and responsive), charities (where researchers did not perform as well as one might expect), and industry where knowledge, understanding and reference to public involvement was negligible. So, to go back to my opening point about institutions and funders, as with NIHR I think that all funders should be requiring researchers to respond with details of how they will involve the public and also making a lay abstract of the proposal mandatory – both at the time of grant application and research publication.

The second barrier or collection of barriers to overcome, reside in our health system itself. When I talk to patients they talk about wanting the NHS to be a ‘National Health and Research Service’ where the research activity of the hospital or clinic is clear from the moment you walk through its doors, where you don’t have to pay privately to go on a clinical trial, where discussions about participating in a clinical trial can be easily and readily had with one’s GP. It is just not happening at the moment. And sometimes it has as much to do with professional attitudes as the systems and regulations themselves.

When the Association of Medical Research Charities (AMRC) together with the other partners of the UK Clinical Research Collaboration (UKCRC) developed this leaflet about the use of patient data in research, we asked both patients and GPs about their attitudes to patient data.
You know what? The majority of patients shrugged their shoulders and told us they assumed it was already happening. Those that had concerns rightly sought reassurances about patient confidentiality.

General Practitioners on the other hand proved highly resistant to having conversations with patients about such matters or indeed talking with patients about clinical trials they could be eligible for. If pressed, they seemed to take up an ever more paternalistic and obstructive attitude towards their patients and medical records.

That leaflet is now out in 6,000 surgeries and it will be interesting what comes back from the evaluation of it with patients and GPs in a few months time.

So systems and professional attitudes…and while on the one hand I am optimistic that the changes being made to the Health and Social Care Bill will benefit research by removing some of these barriers, these are only the end of the beginning in changing the embedded culture within the NHS which has historically not been hostile but not supportive either of the research enterprise in their midst.

The last barrier lies in patients themselves. Much of our focus in the UK on improving the environment for research has been on making the system work better as I say – what I like to call the supply side. Far less attention has been paid to the ‘demand’ side of things, how we equip and encourage patients to come forward more actively, to see research as fundamental to the role it plays in the delivery of their own treatment but that of others in the future, and their role in it.

Perhaps research should be taught as the fourth ‘R’ in our schools, or we should write to everyone on their 18th birthday like political parties do, explaining the compact they are entering into with the NHS including what it does in research as an independent adult, or indeed, simply rebrand the NHS as the ‘National Health and Research Service’ as some have suggested.

I am deliberately being mischievous given that it is a Christmas lecture after all. But I do think there is one thing that we can all do as individuals and from whichever standpoint we come – patient, clinicians and researchers. That is to begin to see people not as ‘research patients’ as David Cameron asks and which has an air of anonymity and us and them about it, but as research citizens in which they are regarded as and involved in research according to the very simple Socrates definition of citizen which is ‘membership of a community.’

Conclusion

Ladies and gentlemen, we have some great things on our side in the UK for promoting and advancing medical and health research:
A strong Government champion in the NIHR
A thriving medical research charity sector connecting with the public
A modern and universal health care system
and
A cohort of research leaders following in the footsteps of Ronald Furlong.

I hope tonight that I have also given you some insight into the unique and inspiring evolution of public involvement in the UK including some of its pioneers. Above all, that it has reassured you that its promotion and advancement will not lead to:
Dodge City
Or even a city built on a seismic fault
But a settlement where research is a way of life for all its inhabitants.
Thank you.

December 1, 2011

Health Research Authority (HRA) commits to public involvement from day one ^Reply

Health Research Authority (HRA) • Tags: AMRC, health research authority, HRA, INVOLVE, NRES

The Health Research Authority (HRA) has published the plan for what it will be up too in the months leading up to March 2012. Really pleased to see a commitment under the Governance section (para 3.3) to develop a comprehensive plan for public and patient involvement.

You’ll see the statement mentions working with both INVOLVE and AMRC who did the original patient/public focus group work for the Academy of Medical Sciences report on research regulation.

simon denegri's lay review

The public and health research

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