When saying “Yes” isn’t affirmative



Anyone who is experienced in approaching patients to ask if they are interested in participating in research on a regular basis is likely to be aware of, if not familiar with, this phenomenon.  You’ve assessed capacity, gone through the main points of the study and left an information sheet with a patient.  You come back.  You ask them some questions – they seem happy to go ahead with the study, they even say as much.  But you aren’t convinced.  Something isn’t quite right – it may be intuition, it may be a hesitancy, it may be something they have said, it may be that they have no understanding of the study at all.

In a time where success of research is often measured in how many participants taking part in studies, there is a pressure to recruit.  Of course there is and that is not a bad thing.  We need people to take part in research for it to be successful and to ultimately improve patient care/ treatment.  So, shouldn’t we just go with it…. if they are saying yes anyway…?

In the youtube video “How do you know a patient has read and understood the PIL?” I’ve given some tips for how check for understanding and explore why it is that we sometimes find ourselves in the situation where someone is saying they will go ahead with the study even though they have no understanding of what the study is about.  In my experience it tends to be one of 3 things; the most common being that they just want to make you (or the doctor) happy.  Other reasons I’ve come across are that they are unable to read (maybe they didn’t bring reading glasses or never learned to read) and also that they are temporarily lacking in capacity and just simply cannot take on board any more information.  Maybe when you left the information they had just arrived on the ward but have now seen the surgeon, the anaesthesist, the phlebotomist, the nurse who has carried out various assessments, had dinner… the list goes on!  They are tired, that have already taken on board lots and lots of information.  You may have come across other reasons – please let me know, everyone’s experience is very different.  It could be a mixture of all the above of course and a few careful questions, alongside a willingness to reassure them they don’t have to take part often gets to the bottom of the dilemma.

Respect for Autonomy is one of the key ethical principles set out by Beauchamp and Childress who assert that

“respect for autonomy in health care relationships requires much more than avoiding deception and coercion.  It requires an attempt to instill relevant understanding, to avoid forms of manipulation, and to respect a persons’ rights.”

Beauchamp and Childress (1979) The Principles of Biomedical Ethics, 7th Edition, Oxford University Press p121

We are busy.  We need people to participate in our studies.  The pressure we feel can be acutely real especially in places that monitor our individual consent rates.  But we must make sure we go through the process of consent properly and trust our instincts to lead us to explore a situation a little more.  It is important that the person understands what we are asking them.  Not just because we want them to be well informed and in order to uphold the principles of consent, but also because high quality research requires high quality data and interactions with participants.  Anyone who has had a monitoring visit know how important completed Case Report Forms are! It may turn out that that person does indeed go on to take part in the study; they may just need a little more time or explanation.  It may be that you need to try and find them some reading glasses or even to read the Patient Information Leaflet out in full to them.  Finding out the reason for the situation will hopefully lead you to the remedy.  And we need to be prepared that sometimes this will mean walking away, with thanks for their time and with our genuine reassurance that it’s OK for them not to take part.


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