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?