Adults Lacking Capacity to Consent

Posted on Apr 3, 2011 by Kelly Gleason in informed consent, Research

In my search to better understand informed consent of adults lacking capacity, I came across this great toolkit on the NRES website which was developed by the University of Leicester and the University of Bristol.

It is called a toolkit but it is more like an online module on research involving adults lacking capacity to consent.

It states what research is covered by the Mental Capacity Act 2005, which is mainly non-CTIMP research in England and Wales. Scotland is governed by the Adults with Incapacity (Scotland) Act 2000 and Northern Ireland is currently covered by Common Law.

The toolkit also discusses the EU Medicines for Human Use 2004 as this is the law that governs clinical trials or CTIMPs.

Throughout the toolkit they discuss the differences between CTIMP and non-CTIMP research. For example, with non-CTIMP studies, the Mental Capacity Act states a consultee must be consulted for advice as to whether of not the person lacking capacity should participate in a study but with CTIMPS, the EU Medicines for Human Use 2004 declares a legal representative must give consent for the individual lacking capacity to give consent, not just give advice.

There is also a section where they discuss emergency situations and intrusive research is defined and how both CTIMP and non-CTIMP research is approved by flagged Ethic Committees trained to review projects involving adults lacking capacity to give consent.

The toolkit is full of tips and ideas for upholding the 5 principles of the Mental Capacity Act and which sections specifically, of both the MCA 2005 and EU Medicines for Human Use 2004, are relevant to research involving adults lacking capacity to give consent. The legal source, the terminology and process varies for CTIMP & non-CTIMP research but the ethical considerations seem very similar.

5 Principles of the Mental Capacity Act

A person must be assumed to have capacity to give consent unless it is established that they lack capacity
A person is not to be treated as unable to make a decision unless all practicable steps to help him to do so have been undertaken without success
A person is not to be treated as unable to make a decision merely because he makes an unwise decision
An act done or decision made, under this ACT for or on behalf of a person who lacks capacity must be done, or made in his best interests.
Before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person’s rights and freedom of action.

They describe who can act as Consultee and who can act as Legal Representative.

There is also a great, easy to read diagram showing an overview of the process in recruiting adults lacking capacity in CTIMP and non-CTIMP research.

It is a bit long to go through and unfortunately the slides are not numbered so you have to click through them all to get back to your place if you have left it and gone back to it but I think this is a really useful online learning tool that is easy to understand and comprehensive.

If you would like to take a look, you can find the toolkit at https://connect.le.ac.uk/alctoolkit/ . You can also access the toolkit on the Clinfield Resources page on under Toolkits and Tools.