There was a story in The Times 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, quite literally, many of us have given it passing thought and said ‘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 blunt and cumbersome process for codifying a very human, perhaps even humane, act. An act that many of us are more than willing to make I should add.
Listening to patients and clinicians has strengthened my view that they 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 does think its God by the way).
The main ‘instrument of perversion’ – as I like to now call it – is the consent form. Often long and convoluted it flies in the face of all the evidence about how people absorb Information and build understanding. Nor does it mirror our life experience of 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.
As important as the dreaded 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.
Finally, we seem to approach consent as a one-off moment of decision-making into which we 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 trying 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 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?