Is the heading of this article in the BBC news today. The article argues that too few patients are volunteering to participate in a particular research trial.
The problem is described thusly:
Our own experience of this phenomenon is the conduct of our stem cell trial designed for patients brought to us as emergencies suffering a heart attack.
The possibility of using a patient’s own stem cells to repair the damage caused by their heart attack could benefit the thousands of people suffering with this condition each year.
Stringent laws and regulations are in place to ensure that trials of such new therapies are carefully conducted and the patient’s health protected.
Indeed the ethical process dictates that patients are given as much information as reasonable to make an informed decision to consent to the trial.
The problem is that in the emergency situation there is an awful lot of information to convey in a short time to obtain ‘informed consent’.
Clearly a balance is needed, given the tremendous potential benefits these new treatments could deliver for these conditions.
In our stem cell trial, brief preliminary consent is obtained as the patient is treated for their heart attack.
Invariably, the patient is keen to participate.
Patients from more privileged areas are more likely to be recruited to our trial than those from the lower socio-economic environment
However, several hours later, following successful treatment of the heart attack, when the patient is approached to consent in full for the main part of the study, they often decline.
Whilst this is understandable, given the relief the person must be feeling having been successfully treated for their heart attack, it creates a problem for the field of medical research which tries to improve on the success of modern medicine.
Where to start?
Firstly it is unclear that there is even a problem here. It looks like on the face of it that patients are being enrolled in a research project with very little time to digest whether they want to participate (understandably because of the emergency situation) and probably with a fair element of therapeutic misconception and then given more time to reflect, and no obvious therapeutic benefit for them they decline to participate any further. Looks like a win for respect for autonomy to me.
The issue presumably is that too many people exiting the trial threatens its viability – but surely the answer here is more resources, or a larger/longer study with more participants – rather than considering patients as obliged to participate in research.
By David Hunter