informed consent

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.

 

There was a story in The Times (pay wall) yesterday about the successful campaign being run through Facebook in the US to get people to become organ donors. Thousands of people have responded to the message passed from friend to friend. Similar success has been had in the UK. My Citizens I can tell you that, quite literally, many of us are giving it passing thought and saying ‘yes.’

I was drawn to this story because, at the conferences I have attended over the last week, there has been an active discussion about how patients are asked to give consent to take part in clinical research. It has left me wondering not just ‘what it is for’ but ‘who is it for?’

We seem to have developed the most cumbersome process for codifying a very human, perhaps one could even argue humane, act. An act that many of us are more than willing to make I should add.

Listening to patients and clinicians these past few days has strengthened my view that they both feel the hand of others on their shoulders at the point of giving/taking consent. And I’m not talking about history or a higher being. No, it’s lawyers, managers and others they sense breathing down their necks (actually one of the above categories does think its God come to think of it).

The main ‘instrument of perversion’ – as I like to now call it – is the consent form. Often long and just as often convoluted it flies in the face of all the evidence about how people best absorb Information and build understanding. Nor does it mirror our changing life experience for how we give consent in other contexts. For many patients and their relatives I am sure it must feel like an out-of-body experience but without the light at the end of the tunnel – no wonder it is cited by people as a barrier to participation.  Yes, it is a blunt instrument indeed.

As important as the dreaded or should I say dastardly form, is who is involved in the conversation on the professional side. Often the rules do not allow it to be the person with whom a patient has – or will have – a close relationship with during the research. I know this is a common gripe of clinical research nurses whose role in partnering patients in research seems completely underplayed and under-valued.  That just doesn’t seem right or even practical and stands as another barrier in itself to recruiting people to research.

Then there is the fact that we seem to approach consent as a one-off moment of decision-making into which we try to cram as much as possible. To put it another way, we are trying to do too much in one go. It can not – in fact I know it does not – lead to a good understanding in many patients about what is going to happen, the risks and benefits. (See the work cited elsewhere on this blog about people’s understanding around placebo for instance).

So what to do?

When I asked my wife what would help her to give her consent to take part in a trial she said: ‘I would like to know what I want to know’ and talked about having a framework which helped her to prioritise information according to her needs and questions and interrogate it in her own way and under her own steam.

Thankfully this participant-led approach is something others are beginning to develop. From the use of online consent in bedside tablets (as I heard in Oxford), to DVDs and videos (PATH Biobank in Germany) or the redesign of forms and accompanying literature to include flow-charts and visuals etc. Others are trying a more deliberative approach with patients which occurs over a longer period of time.

As an aside, in India – where the conduct of clinical trials is being reformed to stop the continued abuse of participants by pharma and their contract organisations – they plan to cope with low literacy levels in the population by taking consent on video. Well, why not here?

A job for the Health Research Authority (HRA)? Actually, there’s no reason why we as patients could not or indeed should not come together in an innovatorium to radically redesign the consent process, develop models and campaign for national adoption.

All I know is that the current system is creaking and needs to change before it croaks it.

What do you think?

The Organisation for Economic Co-operation and Development (OECD) yesterday waded into the increasingly feverish debate about the regulation of clinical trials with a strongly worded recommendation calling on its members to harmonise approval processes.  The recommendation which is worded with the minimum of fuss, is backed by a more detailed explanatory memorandum.

But I am disappointed that the specific recommendation on public involvement from the OECD Global Forum on clinical trials  in October 2011 has not been carried through to inclusion in the documents issued yesterday.  As far as I can see anyway. The Forum had stated the following:

C.3 Increase patient involvement in clinical-trial processes
More direct involvement of patients in the design and monitoring of clinical trials – as well as
their contribution to improve the quality, safety and relevance of clinical research – is of
critical significance for the success and impact of clinical science as a whole.
The roles of patients in clinical trials should be strengthened by means of:
 Mandatory participation of a representative of patients’ opinion in ethics committees
(as such, they would be involved in the decision regarding future risk categories of
clinical trials).
 Consultative and participative role in the planning, design, conduct, dissemination
and implementation of results from clinical science, in part mediated through the
activities of the global networks as well as their regional and local network members
and through other relevant channels.
 Simplified informed-consent documents, containing the vital information for decision
making, using shorter and pedagogically sound explanations.
 Accessible information, for patients, families and the general public. This should
include educational websites, ad hoc documents and open dialogue sessions with
clinical staff at the hospital/clinical unit level, and transparent access to clinical
registers and information databases about planned, ongoing and completed clinical
trials by regulatory authorities.

I’ll do a bit of follow-up and report back!

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

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

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

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

If only petrol was as plentiful a resource as public attitudes.  There is no end to the extent to which we can mine what the public thinks about this, or that.

Occasionally a survey will hit a rich seam of information and insight.  Then again, so numerous are those who are drilling into the public mindset nowadays, that I fear the small nuggets of interest reaching the surface are not without risk.  How long, I wonder, before the mountainous scree of data and information of dubious solidity reaches such a height that it obscures our horizon?

Heh ho! We can but hope that each in turn will move us a little further forward to where we want to get too, and that none do too much harm.  Have they asked the right questions, is it actionable, can we do something with this? These are the questions we should ask of such forays into the public consciousness?  And these two surveys do take us a little bit further forward I think…

Last week PatientView published the results of a survey it has conducted of 400 patient groups on the question of: what do patients value in healthcare?  There are some thought-provoking results embedded within it.  The fact that patients rate relief from symptoms and pain as highly, if not more so, than treatments which increase life expectancy is an affirmation of an issue that has long been articulated in the patient community.  Of all the money spent on researching new treatments and interventions, how much might be better directed at studying and mitigating the consequences of illness which impair a person’s quality of life?  Or simply making those innovations whose worth is already proven work better in the field – as Richard Smith, the former editor of the British Medical Journal (BMJ) suggests in his eloquent blog this week.

This week, I went to a preview of the results of a new report by the Wellcome Trust and the Medical Research Council (MRC) which will be published online shortly, entitled: “Assessing Public Attitudes to Health Related Findings in Research” this week.

It doesn’t quite do what it says on the tin because you could take that title to refer to giving feedback generally to participants in research?  (It doesn’t happen in case you are wondering).  In fact, the report is an examination – through survey and deliberative work with the public as conducted by Opinion Health – of people’s attitudes as to what should happen if researchers and clinicans discover something that has direct significance for the health of someone involved in a study.  I’ll let you read the findings for yourself in due course as they are worth reading as at least the basis for discussion on what should happen in this tricky area.

To be honest I was more absorbed by the mood music of the audience discussion afterwards: the view expressed by more than a few that ‘informed consent‘ for patients is a myth given that doctors are often making an informed guess about diagnosis and treatment; the sense that these dilemmas are not new ones to us but that the real difference is the amount, and  pace, of research and discovery and our capacity and capability to deal with the issues on such a scale and; that there is a need to think in terms of patient rights rather than patient preferences.

The most salient remark, however, was that perhaps we have reached a point where we need to re-think the way we do research; that it should no longer be seen as something that specialists do but should be conceived as the product of an evolutionary partnership between patients and researchers.  Actually, it wasn’t so much the remark that made me prick up my ears as the fact that it came from one of the industry representatives in the room.

There is much to praise about the two studies above.  But if only I could say the same of others.  For I do find myself coming away from reading or hearing other surveys feeling that the underlying premise for them is wrong and what they show, next to useless.

If I had a ‘£’ for every survey that reputedly showed the public doesn’t understand medical research or science I’d be able to open my own version of the Wellcome Collection.   But I wouldn’t know what to put in it because the question is often put so generally that the answer can’t possibly tell me much.  What don’t they understand: it’s value, the difference it can make to lives, why it is an important part of what the NHS does, why they need to take a certain medicine for their condition? Or do you mean how an MRI scan works, or the genetics of Alzhiemer’s?  If so, that’s a bit like saying you don’t understand football because you can’t relate the off-side rule in all its glorious detail.   However, we can’t really debate this further because the question doesn’t allow us.  Shame that.  But don’t worry, it probably props up a lot of misdirected or public engagement work so that’s ok.  Actually, it really is a shame.

Perhaps we need to give the public a bit more credit, beginning with the questions we ask of them.

European Union
Image by erjkprunczyk via Flickr

Daniel Cressey at Nature has written this report from last week’s meeting of the European Forum for Good Clinical Practice which took place in Brussels.

The basic thrust of the discussion at the meeting was that information given to patients prior to them signing up for a clinical trial: is often vague, too long, doesn’t communicate clearly about the risks, and is full of jargon.  The upshot of the evidence is that we are all failing in our duties under the EU Clinical Trials Directive to ensure that patients are fully-informed about the risks.  This is what is known in the trade as ‘informed consent.’

Interestingly the meeting heard evidence from countries outside the EU as well, including the US.

EFGCP is planning to produce a template ‘form’ for all.  Their webiste is here but it is probably too early for a report and the presentations from the conference to appear on their site just yet.

Good ( in a roundabout way) to have affirmation of the first of my suggested ‘bill of rights’ for those taking part in medical research (see post from earlier this year).