HRA

White, middle-class and well-connected – and that’s just the patients: is this the health research culture we wish to see in the UK?

Ever since it was established in 2011, the Health Research Authority (HRA) – the UK regulator of health research whose mission is ‘to protect and promote the public interest’ – has commissioned a regular survey of the general public’s attitudes towards health research.

Today sees publication of the latest of these surveys, this time jointly with the National Institute for Health Research (NIHR). The survey was conducted in April 2017 by Ipsos MORI summer and consisted of face-to-face interviews with 1014 adults aged 15 and over. The survey findings are the most recent insight into UK public attitudes to be published.

Some clear positives emerge from report which you can find here. Also on the NIHR website here.

Consistent with other surveys (including the last HRA one in 2014)  showing strong public support for health research, 83% of respondents said that health research is very important. 91% of respondents said they would be confident that they would be treated with dignity and respect if asked to take part in a research study, compared to 89% in 2014 and 82% in 2013.

Given the UK’s patchy history of engaging the public in a debate about the issue of personal data. Not to mention the  national data opt-out programme being rolled-out in May. We can take some encouragement from today’s findings which suggest increasing public confidence about how their data is treated. 80% of respondents said they would be confident that their personal data would be held securely if they were asked by their doctor to take part in a health research study in the UK. 26% of respondents said they would not be. In 2014 the respective figures were 72% and 18%.

On some issues, however, opinions seem rooted to the floor. People still have least confidence in health research studies undertaken by the pharmaceutical industry.  But on the other hand, the knowledge that people’s confidence in pharma research grows once they know it works closely with the NHS, may be a foundation for promoting further partnership working which shows a different side to the industry. I am sure this will be an important topic of conversation at the AMRC/ABPI Patients First ‘Pioneering Partnerships’ conference on 20th March.

But perhaps the starkest findings for me are those that shine a light on the differences in attitudes to research across different groups related to ethnicity, social class and working status.

If you are white your expectations of being treated treated with dignity in health research are greater than if you are from an ethnic minority (52% versus 35%). The same is true if you are better off (59% of those in social class AB versus 39% of those in social class DE). And the findings point to a similar picture when it comes to educational level. It is also worth adding that only 26% of respondents from an ethnic minority were very confident about the use of their data compared to 37% of white respondents.

These differences matter. Last year a slate of policy reports was published that highlighted the need for health research to collectively change its ways if it was going to produce knowledge and outcomes that reflect the needs of an increasingly diverse population. This includes breaking down the barriers that make people from these groups less likely to want to be part of research.

But nor are these differences new to us. The ‘Going the Extra Mile’ strategic review of public involvement in the NIHR highlighted diversity as a key issue issue which has resulted in a dedicated work-stream being taken forward by INVOLVE . Look out also for publication of the final PPI standards by the four UK nations on 20th March. However, in other countries the debate about under-representation of certain groups has raged more strongly.  This article is quite a good example of how that public discussion is unfolding in the United States.

But given the highly collaborative health research system we have developed in the UK perhaps we have an opportunity to use this strength to collectively take prolonged and considered action where others might find it more difficult to take a strategic approach. But it will require leadership from the very top as well as action at grassroots level, working with community leaders, voluntary sector groups and others who can build bridges in meaningful ways.

 

James Joyce once said that opinion polls were like children digging up flowers to see if they were growing or not. But sometimes such polls are important in highlighting issues and pinpointing instances where some re-planting is necessary. In this instance, my sense is that we need to be growing research in the communities and places where under-represented groups in research live and work. Not be expecting them to come to us.

Have a good day.

(tomorrow I’ll be having a quick look at some of the other findings in the survey and what they mean for health research and public involvement).

There is much post-Brexit talk of using our new-found political independence to liberalise clinical trials in the U.K.

We can cut ourselves free of all that terrible EU red-tape that has weighed us down. Or so the argument goes. We can be quicker and more efficient than other countries. We will be more attractive to research funders and the global pharmaceutical industry in particular.

I am not so sure it will be that easy to extract ourselves completely and utterly judging by the furrowed brows across Westminster and Whitehall.

Nor am I sure we can lay the blame for our trials and tribulations in clinical research totally at the door of the EU. That’s if you accept the picture of doom and gloom that has been painted. I don’t.

We have recovered our international position well in clinical research in the last 10 years. Just look at the number of trials that are first to recruit in the U.K. This is down to the NIHR and its willingness to take on a range of vested interests at home – interests that were far more of a barrier than any EU law.

What I do know is that if things go belly up in the future we won’t have the EU to use as a punch bag. We will only have ourselves to blame.

The yet to be published and ironically named Accelerated Access Review is just such an example of how we are quite capable of slowing things down on our own in the UK. Right down until all the voices are distorted. We really don’t need any help from others.

Not everyone will greet the idea of liberalising clinical research with unbridled enthusiasm. The consumer experience of deregulating markets and cutting red tapes is not always wholly positive. Choice can come with a price. I say this as a frequent passenger on a semi-rural bus service. Need i say more.

Frankly, I wonder whether liberalisation is really the best we can for a post-Brexit moonshot. Surely liberalisation is the means to an end not the end in itself?

I would much prefer us to use liberalisation as a platform for the UK to change the face of clinical trials globally. To be the one that everyone watches.

To become the most innovative nation when it comes to clinical trial design; to be the nation that understands and reflects the patient experience of research better than ever; to be the nation that involves patients and carers in designing all its trials because this way leads to greater effectiveness and efficiency. Total public involvement in the way that Barcelona FC play ‘total football.’

However we got here, we now have an opportunity to do something amazing with patients and the public.

You probably don’t need to hear another thing about the EU, do you?

(By the way what a terrible EU referendum campaign it is – have you ever heard such hyperb******s from our politicians?)

But this really is a good thing.

Following the passage of the new EU Clinical Trials Regulation, the European Commission has started to issue consultation papers on the implementation of its different parts.

One of these concerns the provision of clinical trial results in a format that is understandable by the lay person.  It was issued on 1st June and is out for consultation for three months.   The actual document can be found here. And the page that details the consulation process is here (you will need to scroll down as there are three different consultations).

An important aside is that the guidelines were developed by an expert group led by the UK’s Health Research Authority (HRA) and chaired by the former Chair of INVOLVE, Sir Nick Partridge. So, quite a feather in the cap for the UK.

Interestingly, the HRA points out to me that it was not possible to refer to reading age in the document because only the UK and the USA use this concept and it is not commonly used across the rest of Europe.

You learn something new everyday but only if you are working with others.

 

 

When I was growing up I used to help my Dad do DIY around the house.  Our perennial companion was a thick, hard-bound manual with step-by-step guides on how to do anything and everything.  No job was too big or too small for it.  From replacing a chimney stack to changing a plug.

Dad passed the manual on to me.  But years of use took their toll on the trusty tome,  the spine gave way and pages were lost.  Now we have Google, YouTube and all sorts. But there is still something I miss about that manual.  The sense that when you opened it, years of experience oozed through its clear instructions and helpful pictures.

We don’t have a manual for public involvement. Perhaps we should (Discuss?). But we do have a manual for doing research.  It’s called the UK Policy Framework for Health and Social Care Research and the Health Research Authority (HRA) – together with the Governments of Scotland, Wales and Northern Ireland – are consulting on a new version which you can find here.

To quote the official record, the Framework sets out ‘principles of good practice in the management and conduct of health and social care research in the UK…..It will replace the four separate Research Governance Frameworks previously issued by each UK Health Department.’  This isn’t some bit of guidance that is left on the shelf to gather dust.  It’s the foundation stone for ensuring that research is promulgated in the public interest.

HRA’s grown-up attitude to public involvement is reflected in the fact that references to  public involvement – and the need to protect and promote the public interest – are peppered throughout the document.  Attention to getting the detail right will be important.  In the  ‘literal’ world of research, requirements need to be spelled out precisely if they are to be acted upon. As patients we know that things will often not happen unless they are set out in this way – the devil is in the manual!

For instance, it will be important that the Framework is more assertive about the responsibility of researchers to acknowledge the contribution of research participants; to make the results of their work readily available to these partners.  Also, what this looks like in practice: how does a researcher go about achieving this goal?

Should there also be a section setting out the responsibilities of patients and the public in ensuring good research practice?  The document sets out the principles that apply to organisations and their staff doing the work. But not the citizens involved in making it happen. Should we – you and me – be allowed to go scot-free? What are our responsibilities and duties? 

Finally, I wonder whether we could do with a bit more oomph in the document.  A preamble that will be passed down through the ages.  You might recognise the origins of the following that I wrote this afternoon?

“We the research community of the UK – including patients and the public , in order to do better research to improve health and wellbeing, ensure that it is done safely, in the public interest, and in such a way as to promote and advance the greater contribution of the public to this endeavour, do ordain and establish this Framework for the UK research system.’

Well, you can have your say by taking part in the HRA’s online survey here. Or by attending one of the workshops including two being held for patients and service users in Birmingham (Feb 24th) or London (9th March).  More details here.

Have a good evening.

 

 

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

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

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

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

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

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

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

 

Two posts in one day!  Ah, those were the days when we got two Post Office deliveries a day….

Just to say the Government has published the full terms of reference for its Innovative Medicines and MedTech Review to be headed up by Sir Hugh Taylor who is currently Chair of Guy’s and St Thomas’s.  Yes, that’s the very same review I said this morning would be out any time soon.  Only it happened yesterday!

The remit is comprehensive and the door is very much open to patients and patient groups to give their views.  The specific para of relevance here is as follows:

‘Consider how to ensure patient trust in the regulation and assessment of medicines and medical technology, and recognise the importance of the patient voice and role of medical research charities as both sponsors and beneficiaries of innovation.’

The review is being supported by the Wellcome Trust – in other words they are doing the legwork – and there is a short blog on their website here.  They haven’t announced the other members of the review panel nor details of how it will work. We will learn more in due course.

I think Hugh Pym at the BBC has written a good piece here on the significance of the review for the future of medical research and speedier access to medicines for patients.

Also this from law firm Pinsent Masons which highlights the review focus on digital technologies.