I’m passionate about subject protection in clinical trials, and informed consent is a key part of that. It has its origins in the Nuremberg Code, the Declaration of Helsinki and the Belmont Report as well as in every other regulation or guideline about medical research in human subjects. And we do need to inform subject, I believe in that, but the amount of information we now put into a Patient Information Leaflet (PIL), and the way the information is presented surely must inhibit the average patient’s ability to process the information and make a truly informed decision?
I recently attended a meeting where someone was really pleased that they’d managed to get the PIL down to only 14 pages, and I know that’s considered short these days. I hear of information sheets which are 30 or more pages long. I would argue that it’s unethical to subject patients to that much information, and we really need to rationalise the content and also think long and hard about how we present the information. 30 pages of black and white print would daunt the most determined researcher, let alone the research subject.
The issue is that as well as the elements of informed consent as outlined in ICH GCP we also have data protection, insurance, legal stuff, “can we use your leftover material” stuff etc. etc. All that information is important, but we could break it down more, and emphasise the most important points in a user friendly way.
With the move to online or eConsent and the continuous development of technology we have lots of options now to present information in a more user friendly and interactive way. Obviously any information must be approved by the Ethics Committees, but my impression is that they would welcome improvements, after all they have to read the stuff too!
So isn’t it time to revamp the consent process? Let’s think more about the subjects and less about just ticking the legal boxes. What’s wrong with colour? Or pictures? Flowcharts, diagrams, quizzes? Games even or video clips? Cost is a factor I know, but a few extra pounds developing patient friendly materials could go a very long way to improving the patient experience, which in turn should improve recruitment, retention and compliance.
I love these quotes from the UK’s Human Tissue Authority Code A document on validity of consent:
“For consent to be valid it must be given voluntarily, by an appropriately informed person who has the capacity to agree to the activity in question”
“Written consent, either in paper or electronic format, serves as evidence of consent, but a signature on a form does not of itself make the consent valid”
If informed consent isn’t really informed is it really consent?
1 thought on “Informed Consent – does it now defeat the object?”
Well said! How many ordinary Joe’s are going to read ever 14 pages?,