The Mental Capacity Act 2005 was developed to protect the rights of people who may lack capacity. In day-to-day life this basically means this legislation provides guidance about, should a professional be in doubt as to whether someone has decision-making capacity, how to decide this. Alongside the Mental Capacity Act Code Practice, it provides practical examples of how to judge if a person can understand, retain (long enough to make a decision), weigh up and express a decision. Importantly for researchers the Mental Capacity Act 2005 also provides guidance to researchers about the process to follow when gaining consent from a research participant. Now the Mental Capacity Act 2005 applies to the legislative regions of England and Wales, there are separate pieces of legislation for Scotland and Northern Ireland. Of course, other countries also have their own pieces of legislation. This is also important information for researchers to bear in mind when they are undertaken large multicentre international studies.
In my mind this legislation can be considered a Bill of Rights for people who may lack capacity. Rather than allowing people to be branded with globally lacking capacity, this Act emphasises that decisions are time and decision specific. It also emphasises that people may be able to demonstrate their capacity through means other than talking in English, through other languages including signing or modalities such as gestures or writing. Unfortunately, despite this Bill of Rights- the legislation doesn’t always enable increased participation in decision making. May researchers find this legislation and the code of practice to be complicated and difficult to follow. Researchers are often not given lots of training in this area, they are more or less expected to pick it up on the job. Very often they aren’t given any tools to help them in consenting people to their studies either. In fact, just the opposite, they are often asked to use complex, long consent forms that even they find hard to follow. How can people with communication difficulties arising from dementia such as language difficulties, visual-perceptual difficulties or attention and cognitive impairment – even mild ones- be expected to engage with these types of forms? This means that very often people with dementia who have any difficulties in consenting are either deemed as lacking capacity to consent, and their relatives have to act as consultees OR they are simply excluded from the study. This in turn means that lots of studies exclude anyone with a speech or language difficulty, or a visual or hearing impairment.
It seems rather short-sighted to turn people away from a research study based on such a concrete and easy to resolve barrier in my mind. The research states that in general, people are most likely to fall on decision-making capacity assessment because they struggle with understanding information. So, for starters, if only consent forms were routinely designed to be accessible by people with dementia. In fact, co-designing consent forms and information sheets with Patient and Public Involvement input seems like a bit of a no-brainer. There is more and more guidance available on this – and ethics committees are slowly coming up to speed on this too. Secondly, surely training researchers to support people to understand the information they provide would also be useful. Many of the researchers I have spoken to over the years are not used to translating things into lay language, they might not be used to using drawing/pictures/gestures to support interactions themselves. If only they had access to training and guidance on this. Our recent paper flags this issue and declares a “call to arms” on supporting complex and alternative consent pathways for people with communication difficulties, with fluctuating capacity and who already lack capacity. This feels important for the dementia field. So, perhaps in your next research study think harder about this- find out what you could and should do in terms of supporting consent processes. Perhaps even report your consent processes more fully! Then we can share practice and improve practice.
Reference: Russell, A. M., Shepherd, V., Woolfall, K., Young, B., Gillies, K., Volkmer, A., … & Wade, J. (2023). Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action. Trials, 24(1), 151.
Dr Anna Volkmer is a Speech and Language Therapist and Senior Research Fellow in Language and Cognition, Department of Psychology and Language Sciences, University College London. Anna is researching Speech and language therapy interventions in language led dementia and was once voted scariest speech and language therapist (even her children agree).
Leave a Reply
You must be logged in to post a comment.