It is a cardinal principle of the Mental Capacity Act 2005 (‘MCA’) that those responsible, including doctors, care workers, family and the court, must be fastidious to evaluate capacity on an issue-specific basis.
Hayden, J QJ v A Local Authority & An NHS Trust [2020] EWCOP 7
Most research nurses will have undertaken “Informed Consent” training. It’s a core part of our role to be able to “assess capacity” and approach patients to see if they would be interested in a particular study and subsequently receive consent (or not!) for their participation.
As a nurse with a special interest in the consent process, I’ve facilitated such sessions for many years now and my interest has led me to seek out further understanding of the law. As such, I am looking forward to hopefully completing my LLM/Masters in Medical Law next year after 3 years of study.
Being aware of the Mental Capacity Act 2005 and the principles has led me to reflect on what these might mean for us specifically as research nurses. The principles come right at the start of the statute, taking front and centre stage. They cannot, and must not, be ignored.
A person must be assumed to have capacity unless it is established that he lacks capacity
The Mental Capacity Act 2005
This “presumption of capacity” principle takes the top slot. However, this doesn’t mean it’s necessarily any more important than the others. In fact, as Judge Hayden says in the case quoted at the top, “Each of these principles is fundamental to decision-making and each is of equal weight and value.”
I’ve seen this principle misunderstood quite often; in fact, I certainly didn’t really understand it properly myself for many years.
The principle places no onus at all on the patient to prove anything. In other words, they do not have to demonstrate to us that they have capacity to make a particular decision at a particular time. Quite the converse in fact. The onus is on us to establish that they do not if that is the case.
We must be clear on why we believe this to be the case and evidence it. When I am delivering “Informed Consent” sessions, I always talk about the practice of “cherry picking”. The practice of judging a patient and their suitability for a study based on their demeanor or other subjective categorisation should have no place in research. Personally, I think if we can’t document on the screening log the reason a patient is not eligible for a study as something listed in the protocol, we’re not doing our job properly. Subjectivity introduces bias and prejudice and that’s definitely not something we want in our clinical trials. Our patients deserve better and we must uphold and advocate for their rights.
As we (hopefully) all know, capacity to make a decision can fluctuate and this is also something we need to bear in mind with our documentation. It’s pretty meaningless to say “the patient lacks capacity”. Capacity for what? We must be specific in what we are talking about. They may well be able to decide what they want for tea, but not whether or not they wish to participate in the study. Remember to specify the time point and the specifics of the type of decision to be made.
The ethical principle of respect for autonomy is really important to uphold when considering the consent process. There are other principles both ethical and from the MCA (2005) I’ll not go into detail about here, but this essentially is about patient choice.
The landmark Supreme Court decision in Montgomery v Lanarkshire Health Board (2015) made it very clear that we were entering a new era.
One development which is particularly significant in the present context is that patients are now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession. They are also widely treated as consumers exercising
Montgomery v Lanarkshire Health Board (2015) UKSC 11
choices: a viewpoint which has underpinned some of the developments in the
provision of healthcare services.
So, the next time you approach a patient remember this principle and think about whether there are any ways you can be more objective in the process you go through. As always, please do let me know your thoughts. Thank you for reading.
Receiving Consent 