Today’s rare foray onto the UK political scene by Tony Blair reminded me of a simpler time when politicians just used to repeat the same word three times for added emphasis. Or was it the daleks who used to do that? Funny how nightmares and the stuff of dreams can sometimes get confused in this way.
Should either take it upon themselves to return to earth and make medical research their thing, whose to say that their mantra would not be ‘consent, consent, consent.’ But it’s how they would say those words that would matter. Both would be speaking the same language and talking about the same thing. Yet their delivery would be key.
Try it. Find somewhere where you can be alone and then say ‘consent’ three times – first in Blairite tones and then as if you are a Dalek. Now imagine you are a patient and tell me which would reassure you most. As any dalek will tell you, their group therapy sessions are dominated by worries over communication.
Yesterday the Health Research Authority (HRA) published the report of its second public dialogue exercise supported by Sciencewise (and which I Chaired). This one looked at three issues:
- Who can access my patient notes to tell me that I might be eligible to take part in a study
- Different ways in which people can register their willingness to take part in research
- Simplifying the consent process in clinical trials of already licensed products
You can see the key findings below:
- The majority of participants did not believe that research nurses currently had access to patient notes in hospitals or GP surgeries. However the majority of participants were open to the idea of research nurses having access to patient notes with the proviso that patients are informed and have the ability to opt-out. For research active practices, posters in the waiting room were not seen as being sufficient to ensure all members of the surgery were actively informed about changes to access to patient records.
- Whilst the majority of the participants accepted the use of consent to approach (or consent4consent) lists in principle, there were concerns about both of the models reviewed. For approaches in the waiting room, participants wanted sensitive, common sense approaches by someone identifiable as being attached to the hospital. There was a preference for this being a member of NHS staff., not by other patients or third parties.
- For approaches by post, the participants were concerned that many people would not read the leaflet or realise they had consented by default to be on the consent to approach list. A sufficient length of time was required before participants were assumed not to have opted out.
- The majority of participants supported the use of simplified consent. The opt-in model raised fewer concerns about the impact on patient- GP relationships than the deemed consent model. Most participants agreed with using a simplified patient information sheet which did not repeat the information contained on drug pack inserts. Most people agreed with the use of zero consent in an appropriate low risk example as might be allowed in future cluster design trials under forthcoming regulations.
This a purely personal view but there seems to be a signal in this work that the public are open to a more flexible, proportionate and common-sense approach to consent in medical research. This is very important. My own direct experience of working on the 100k Genome Project and talking to patients is that what we institutionally define as necessary to ensure informed consent can have the reverse effect: obfuscation and misinterpretation. We are certainly not helping them and their families, and we are not helping ourselves by sticking rigidly to out-of-date practices.
I am also very pleased that the exercise provides us with some evidence that the public have an appetite for seeing research nurses take on a bigger role in recruiting people to take part in research. I do feel that their skills, their ability to build open and honest relationships with patients is something that we under-utilise. When I hear patients talking about their experiences of being in research they often talk about the important role played by research nurses at different points in the process. And particularly in the very beginning.
I think we are seeing a slow march towards a simplified consent model and, hopefully one day, dynamic or personalised consent. From a patient perspective the most important issue will be then as now, the quality of the information provided and the way in which it is communicated.
Have a lovely evening.