Consent and capacity of people with dementia

Traditional approaches to ensuring informed consent may be too reliant on cognitive ability for the  person with dementia. 

For consent to be freely-given and fully informed, the participant must:

• have,and understand,  all the relevant information about the activity
• be competent to give consent
• not be under threat, duress or inducements
• be able to withdraw at any time.

Participation information sheets and consent forms

Giving a participant information sheet, which they read (with  support, if necessary) can be a good way to get consent (though it won’t be appropriate in all cases).

• How much information you need to provide, will depend on what you are asking people to do or tell you.
• Make sure you write your information sheet in language that the people you want to involve, can understand.
• Avoid using acronyms and jargon where possible.
• Make sure the people you are looking to involve have read and understand the information you have provided. You might like to recap it at the start of involvement activity to check everyone is clear and happy to get involved. 

A participant information sheet should contain:

• A clear title for your activity
• A brief summary of what you hope to achieve in your activity
• Background information (including why you are doing your activity)
• What’s involved in taking part (including how any data will be used)
• Details of any risks (these should be clearly signposted for people you are inviting to get involved).
• Information on the right to withdraw from the activity at any time.

Providing information in writing, so the person with dementia is clearly and simply informed can be helpful for some people, but additional approaches may be needed too. 

Example of a participant information sheet for a focus group to identify priorities for carers.

Check your organisation's consent policy and practice for consent forms you may need to use. 

Process method of consent

In some situations, a person's ability to give consent may fluctuate, or family may usually be involved in supporting them about making decisions. 

• Get permission to access the person with dementia from staff, family or other named persons.
   
• Decide whether the person with dementia has the capacity to consent to taking part in particular activity.
  • If they do, give information telling the person with dementia about the opportunity to get involved.
    • The person with dementia can then consider the information and decide whether to to get involved.
    • Use a signed consent form to record this consent.
    • Proceed with the activity.
    • Stop and let the person with dementia withdraw before or during the activity
      • If the person with dementia no longer wants, or is no longer able, to be involved.
        • Consider what you observe, as well as what the person says, to guide you about this. 
      • Depending on the situation, it may, or may not, be appropriate to ask them again later if they would like the opportunity to get involved. 

Always start from the assumption that a person has capacity to consent.

Where the person with dementia has capacity they must be enabled to make their own decisions and to share their views.

When they do not have capacity to decide about giving feedback, getting involved, or, for example, consenting to be observed, staff must act in the 'best interests' of the person with dementia, taking account of the Mental Capacity Act 2005 requirements. Carers have an important role to play in sharing their knowledge of the person with dementia to help staff to do this.  

When is it appropriate to research the experience of people with dementia who lack capacity to consent to get involved?

You should only conduct research with people who lack capacity to consent if:

• you cannot carry out the research with only participants who can give fully informed consent.

• the research is related to the condition that causes the lack of capacity or to its treatment

Useful links

Assessing capacity: Alzheimer's Society

Decision-making capacity in people with dementia: SCIE