Medical Research Council
[Aside] Though this be madness, yet there is method in’t.
If you are in some way connected to public involvement in health research then you get used to ‘the look.’
Sometimes it’s a vacant stare or a gaze falling slowly across the face like the sun going down. In other instances it’s a look of panic or sheer terror. ‘Are you mad?’ you can see them think. Then, ‘No, they’re serious and my world is about to be turned upside down.’ This, as they shift their weight from foot to foot.
Demonstrating the logic and rationale behind our passion is key to influencing these panic-stricken colleagues who have stumbled across our world for the first time. Identifying methods and methodology that will not just work for them but make research better and their lives easier is key. Refinement of this thinking and in ways that can be easily assimilated is one of the three grand challenges for public involvement.
It is my personal opinion that we are not doing nearly enough across the NIHR to learn from current public involvement practices, develop appropriate methods and methodology and then serve these up in a way which can be used easily by our friends colleagues. INVOLVE has done some fabulous work in this area not least through its invoNET programme of work and its evidence library. But others need to begin to demonstrate that they will be taking this agenda seriously if we are not to build public involvement on foundations of sand. Across the water, in Canada
The Health Services and Delivery Research Programme is currently on the hunt for future research topics (deadline, 4th December) and this may well be one route to boost efforts. In the meantime there are some studies underway which I hope people will support.
To this end, I am passing on this invitation to take part in the Medical Research Council (MRC) -funded METHODICAL study – initially, a two-round survey to help agree which methods, practices and procedures of patient and public involvement (PPI) in clinical trials should be prioritised for future research…
The notice I received says..
We are looking for people with at least 12 months experience of PPI in clinical trials within any of the following roles:
- PPI Researchers (e.g. those who conduct research into PPI in clinical trials and authors of guidance documents)
- Non-lay Reviewers of trials (e.g. professional members of clinical trial funding boards /Research ethics committees)
- Lay Reviewers (e.g. members of the public sitting on clinical trial funding boards/ Research ethics committees)
- PPI Advisors across trials (e.g. member of Research Design Service (RDS) advising others on PPI activity, PPI advisors from funding bodies)
- PPI Contributors (e.g. patient representatives, research partners in clinical trials)
- PPI Co-ordinators (e.g. working for a Clinical Trial Unit (CTU) or research network to coordinate PPI activity)
- Chief Investigators, trial managers and other researchers/staff who plan/oversee PPI in trials
Each round of the online survey will take about 15-20 minutes. Round one involves scoring the importance of a list of research topics on a scale of 1-9. About two months later you will be invited to complete round two, where you will be asked to review a summary of the survey responses and given the option to change or keep your original scores.
This type of survey is called a Delphi, and is a way of finding agreement amongst a group of people. To ensure the results are accurate it is important that as many people as possible complete both rounds of the survey.
Round one will be available to complete until Friday 11th December.
Some people who complete the two-round survey will be invited to a meeting in Liverpool, at which the results will be presented and discussed to achieve a final agreement of the research priorities. You do not need to be willing to attend this in order to complete the online survey.
More detailed information about the study is available in the attached document.
The survey can be accessed from www.methodicalstudy.uk
We would appreciate your help with the study. Also, if you think there are any persons or networks that this might be relevant to we would appreciate your help with the dissemination of this email.
The Medical Research Council (MRC) has published a refreshed communications and engagement strategy.
There is a section on public involvement on P12 of the document which is the fullest narrative I have seen of their corporate intentions around this aspect of working in partnership with the public.
It is a good document and important to have in the public domain. But I wish the public involvement part had a bit more ‘oomph’ in making a stronger commitment to involving the public in strategic and operational decision-making by the MRC. Also that it appeared earlier in the document and as part of the main strategic aims.
That might help to counter the views some people hold that the MRC’s default way of working with the public is to broadcast high quality
information. For the fact is that there are many excellent examples from the root and branch parts of the organisation which demonstrate how its researchers increasingly see what they do as a joint venture with patients and the public.
The MRC Clinical Trials Unit at UCL has, for instance, produced a set of stunning new videos about all aspects of public involvement including this one.
The strategy does these activities a slight disservice by underselling their importance to the overall strategy of the MRC. However, it does mark a degree of progress.
[This post is on the ‘asides’ pages where I tend to post short pieces. My full posts are on the main pages as usual]
Science historian and Guardian science blogger, Vanessa Heggie (@HPS_Vanessa) has written a fascinating piece about how AIDS activists among others changed the way we run clinical trials and persuaded researchers to adopt new methods.
That’s certainly the history lesson passed down to me as Chair of INVOLVE by previous members. They will tell you that, before we ever talked about definitions, standards, impact or, rather bizarrely ‘what is a patient?’ it was protest and a sense of injustice that drove patients to clamour for change and hammer on closed doors. They will also tell you that our very own Medical Research Council (MRC) was one of the organisations with doors firmly closed and drawbridge raised.
This year, the MRC has been celebrating its 100th birthday. Like every centenarian it will have got a telegram from the Queen saying:
“I am so pleased to know that you are celebrating your one hundredth birthday this year. I send my congratulations and best wishes to you on such a special occasion.”
If I were President I would add a ‘PS:’ But you need to do more public involvement if you want another telegram plus some birthday money next time.
The MRC is a curious organisation when it comes to public involvement. I am in touch with a great many MRC colleagues whose commitment to it is palpable. As I go around the country, patient and public friends are often fulsome in their praise of MRC trials, how they have been run and how they were treated as participants. In October, the MRC Clinical Trials Unit, – a world-class centre of research excellence – held a workshop to discuss how to strengthen public involvement in clinical trials in the future. It is important that we support and encourage such activities in order for them to grow.
But, step closer to its HQ, and things become that bit more hazy. In fact, befuddlement might be the best word to describe its corporate response. Imagine people coughing and shuffling papers on their desk when asked a difficult question and you have it about right. Fact is, they just don’t get public involvement or perhaps even ‘the public.’
The disjointedness between this corporate persona and its more streetwise operational self hit home to me when I viewed their new 2014-2019 strategy ‘Research changes lives.’
This document was published last week. The second of its strategic aims is entitled ‘Research to people’ and this has three objectives including one on ‘Engagement: To enhance engagement and communication with our scientists and partners, policy-makers and parliamentarians, and the public.’ What that means to the cynical part of me is that the MRC remains wedded to the notion of talking ‘to,’ if not ‘at,’ the public rather than taking a more courageous step to involve them in its decision-making.
The MRC has struggled with the notion that people who are not scientists might have something useful to contribute for as long as I care to remember. When I became chief executive at the Association of Medical Research Charities (AMRC) and met its then chief executive, Professor Colin Blakemore, it was clear that engagement was the thing. That meant raising public awareness and understanding. No more, and no less. Professor Blakemore did awareness raising – and does it – very well indeed and he should be applauded for it. It has never really moved from this position since.
I did experience a glimmer of hope some time ago when it was going through a revamp of its committees. But, alas, I was to be disappointed. Its Ethics, regulation and public involvement committee contains many ‘good eggs’ who I admire greatly. But they do not constitute a patient and public forum who could inform and shape the MRC’s decisions and work based upon people’s lived experience of research – whether as participants or interested members of the public.
The thing is, like many old institutions with cultures stronger than their constitutions, the MRC is a good egg that simply likes its ‘good eggs.’ It is attracted to status and titles. And that means neither you nor I, I suspect. So while its doors may be ajar compared to two decades ago, they are also wooden and heavy and cumbersome. That means they are likely to spring back and do you and I an injury at any moment.
That’s a shame because it overshadows the excellent public involvement work being hatched ‘out there’ by MRC staff in their respective field. They’re the ‘good eggs’ in my book.
Off to Liverpool today. I am chairing a session at the Pancreas Society’s first ever PPI forum. This is the opener to their annual scientific meeting which takes place the rest of the week.
Last Friday was another first. I spoke to, and took part in, the inaugural meeting of the MHRA’s ( Medicines and Health Products Regulatory Agency) patient group consultative forum.
Is that the sound of broken shards from a glass ceiling I can hear beneath my feet? Let’s not tempt fate eh?
What else connects Liverpool to our drug regulator?
Well, just a few days ago in Liverpool, the Medical Research Council (MRC) and Sense About Science launched a new public guide on drug safely entitled: ‘Making Sense of Drug Safety Science: Investigating the science of side effects.’ And an excellent publication it is too in talking about side effects and how we are doing more to learn about them. You can find a copy here: http://www.senseaboutscience.org/pages/health-and-medicine.html
But there is more to this issue than increasing public understanding and awareness.
In my experience, drug safety is one of those issues where doctors, researchers and patients are a long way from reaching a satisfactory working relationship.
At root is the clash between ‘scientific evidence’ and ‘patient experience’ with the validity of the latter often disparaged. Typically this is couched in terms of ‘the hierarchy of evidence.’ It is an argument intoned with the same sort of words and feeling that we used to hear from members’ clubs about why it was necessary to exclude women.
We had such a question about ‘evidence’ versus ‘opinion’ to the patient panel from the floor of the ABPI conference last week. I also heard those arguments played out at the MHRA meeting but thankfully with good grace and a willingness on both sides to listen. The resistance to listen and respond is the jagged edge of regulation on which patients often cut themselves.
I am not sure that any patient or patient group is seriously trying to unseat the place of science in regulation. But I do hear them urge that regulators use different instruments according to the environment and context – as pilots do when flying in good weather or bad – to allow the patient voice to be heard more clearly. The same goes with doctors.
If seems foolhardy to me if regulators and the professions do not embrace the ‘informal’ yet undoubted richness of conversations that patients have about their medicines. And we have already seen with some drugs such as statins how the patient voice has been critical in changing practice and attitudes. Or in devising new tools like the medication passport developed by the North West London CLAHRC. If only the system might turn to such creative minds to develop a more patient-friendly yellow card system for reporting adverse events. We might get rid of forms for a start.
With vision we might see patients as an integral part of the regulatory system for improving drug safety. Not the inert mass to be protected.
Yes, regulation might just be the thing for them to cut their teeth on.
At least we are now at the table.
Yes, we are positively swimming in data these days. And I don’t about you, but I’m looking forward to doing some data-linkage with family and friends over Christmas and the New Year.
From a Government point of view, making best use of the data which is routinely collected by departments, public agencies and others, linking it up and enabling researchers to interrogate it in a way which does not impinge on a citizen’s privacy, has been a big topic of conversation this year. What to do?
Well, the Economic and Social Research Council (ESRC), together with the Medical Research Council (MRC) and Wellcome Trust, established a taskforce in 2011 to look more deeply into the subject and has just produced its report and recommendations. They propose the setting up of Administrative Data Research Centres (ADRCs) in each of the four nations of the UK, a single governance framework for them, a common approach to data storage plus some ground rules for publicly funded researchers to access the data held.
They recognise the importance of public engagement and say the overall Governance Board must have at least one lay representative and that each Centre should have a public engagement plan and resource to support it. The report is here.
Meanwhile – and I mention it because I was on the review panel – NIHR has recently announced the successful bids to set up Healthcare Technology Co-operatives (HTCs) which will work collaboratively with industry to develop new medical devices, healthcare technologies and technology-dependent interventions in clinical areas of high morbidity or unmet need. The areas covered include: chronic gastrointestinal disease, brain injury, cardiovascular disease, Devices for Dignity, wound prevention, colorectal therapies, mental health and trauma management. Full details on the NIHR website here.
You might also wish to visit the NIHR home page right now where they have also just listed the year’s achievements – an impressive list.
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.
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.
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:
The rise of citizenship
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.
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.