Volunteering for research into dementia

A great deal of research is currently being carried out into the causes of dementia, its diagnosis and its treatment. The progress that is being made is only possible because people with dementia and their carers are willing to participate in research. This factsheet looks at how to become involved in research and suggests some things to consider before taking part.

In what ways might someone become involved in research?

There are many different ways in which people with dementia can take part in research. They may, for example, be asked to give a sample of their blood for use in genetic research, or may be asked to take part in a clinical trial looking at new treatments. They may also be asked for their views on health and social services.

While it is important that research is carried out, it is also important that the rights of the person with dementia are respected and their dignity maintained.

Types of research

Research into dementia can be divided into three categories: therapeutic, non-therapeutic and health services.

• Therapeutic research may be of benefit to the person with dementia, either during the project or once it has concluded. If the research is a clinical trial with a drug treatment, it should be made clear whether the drug will be available after the end of the study.
• Non-therapeutic research will not directly benefit those who are participating, but will add to the body of knowledge about dementia. The findings may benefit people with dementia in the future. If the research is non-therapeutic, this must be made clear to the person with dementia before they decide whether or not to take part.
• Health services research gives people with dementia an opportunity to improve the provision of services in their area and beyond.

Randomised controlled trials

If someone with dementia is invited to participate in research on a new drug, you may hear the phrase 'randomised controlled trial' mentioned.

A randomised controlled trial is a procedure in which a group of people receiving a new treatment is compared with a 'control group' of similar people who may be receiving a different treatment, a placebo treatment (that is, a dummy treatment or sugar pill), or no treatment at all. Participants are randomly allocated to the treatment or control group by means of a mathematical formula or a computerised system to safeguard against any bias.

The effects of a new treatment are very difficult to measure without such comparisons.

You may also hear the terms 'blind' and 'double blind' used to describe a trial.

• Blind means that the person participating is not aware of whether they are receiving the new treatment or are part of the control group.
• Double blind means that as well as participants not knowing whether they are receiving the treatment or not, those carrying out the research do not know which participants are receiving the treatment and which are controls either. Because of this, their observations are less likely to be biased.

If a person with dementia agrees to participate in a randomised trial they may be given the new treatment, or an existing treatment, or a placebo. It should be made clear whether the treatment is available once the trial is over.

Issues around consent

The researchers must obtain consent from the person with dementia before any research is carried out - even if it is simply a question of taking an extra blood sample. It is not sufficient for the person's carer to agree.

Consent must be adequately informed and voluntary. The person with dementia must be aware of the purpose of the research and what is involved. They must not be pressured to take part in research if they are unwilling to do so - even if the carer is in favour.

The person with dementia should be given plenty of time to consider whether to participate. They may wish to consult their friends or family, or their GP. The researchers should make it clear that even if the person does agree to participate, they are free to change their mind and withdraw at any point. They should also reassure the person that any support or services they receive will not be affected by whether or not they agree to take part in research.

In most cases, the researchers should give the person with dementia an information sheet providing details of the research and the name, address and phone number of the researcher and their supervisor. If the person agrees to take part in the research, they will usually be asked to sign a consent form.

What if someone is unable to consent?

People with dementia will sometimes be included in a research project when they do not have the capacity to give their informed consent. In this situation, research carried out on, or in relation to, a person lacking capacity can be lawfully carried out under the Mental Capacity Act 2005 if an 'appropriate body' (normally a research ethics committee - see below) agrees that the following conditions are met:

• The research must be safe.
• The research must relate to a condition that the person has.
• There must be reasonable grounds to believe that the research could not be carried out successfully if it were confined to individuals who had the capacity to consent.
• The research must produce a benefit to the person taking part that outweighs the risk or burden. Alternatively, if the research is intended to develop scientific knowledge, then the risk to the person must be likely to be negligible, and the research must be carried out in a way that will not be intrusive or interfere with the person's privacy.

Carers or nominated third parties (who can include the donee of a lasting power of attorney or the person's deputy) must be consulted, and must agree that the person would want to join an approved research project. If at any time it appears that the person would not wish to be involved in the research project, then the person must be withdrawn immediately unless withdrawing would provide a significant risk to that person's health.

(For more information, see Factsheet 460, Mental Capacity Act 2005, and Factsheet 472, Enduring power of attorney and lasting powers of attorney.)

Research ethics committees

All research undertaken by doctors and other health professionals that involves human subjects must be approved by a research ethics committee. These committees have been set up to ensure that:

• the research undertaken is morally justifiable
• the highest standards of practice are maintained
• the likely benefits of any research outweigh any possible risks
• participants' rights are properly safeguarded.

Although not all kinds of research will go through a research ethics committee, all researchers should make every effort to preserve high standards.

Checklist: questions to ask

Before taking part in any research, the person with dementia and their loved ones need to consider the following questions:

General

• What is the purpose of the research?
• What does the research involve for the person with dementia, and will they benefit from participating?
• Will other people in the person's life (such as a carer) be involved − and if so, how?
• Where will the research take place, with how many sessions and over what period of time?
• How will confidentiality be maintained?
• Who will have access to the data (such as questionnaires or interview transcripts), and will this information be destroyed once the research is complete?
• Will any necessary transport be arranged and paid for?
• Are there plans to tell people about the results of the research - and if so, how and when?

Health-related research

• Has the research been approved by a research ethics committee?
• Is the research likely to cause any discomfort or distress?
• If the research involves treatment, what are the risks and likely side-effects?
• If the research involves treatment that appears to benefit the person with dementia, can they continue with the treatment once the research is completed?

Where to go with any complaints

If you have any worries or complaints about research that you or someone you know is involved in, take these up with the person in charge. If you are still not satisfied, seek advice from Alzheimer's Society or your local advice agency.

Patient and public involvement in research

Patient and public involvement (PPI) programmes offer a different way for people with dementia and carers to get involved with dementia research. Rather than people volunteering to be research subjects, PPI refers to involving people in the creation, design, implementation and dissemination (communicating results) of research projects. This might involve anything from helping to develop a research strategy, to sitting on a panel to review grant applications, to speaking about publically about research.

Patient and public involvement is increasingly becoming an important part of many research programmes. It gives researchers an opportunity to better understand the experiences of service users, ensures that the research funded is important to people, and can help scientists to communicate more effectively with the public.

Alzheimer's Society gives people the opportunity to get involved in its research programme through the Research Network. The Network is a team of carers, former carers and people with dementia who help to set the Society's research priorities, help decide which research should receive funding, monitor ongoing projects and spread the word about findings. Please contact the Society's Research team to find out more (see 'Useful organisations').

Find out about Alzheimer's Society services in your area

Useful organisations

Alzheimer's Society

Devon House
58 St Katharine's Way
London E1W 1LB
T 020 7423 3500
E info@alzheimers.org.uk
W alzheimers.org.uk

The UK's leading care and research charity for people with dementia and those who care for them. The Research Volunteer Network allows people affected by dementia to get involved with the Society's research programme.

INVOLVE

Wessex House
Upper Market Street
Eastleigh
Hampshire SO50 9FD
T 02380 651 088
E admin@invo.org.uk
W www.invo.org.uk

National advisory group which promotes and supports greater public involvement in NHS, public health and social care research. Produces a range of publications about public involvement in research.

National Institute for Heath Research Clinical Research Network

W www.crncc.nihr.ac.uk

Has information about research for researchers, health professionals and the public. The NIHR Clinical Resarch Network Portfolio is an online database where people with dementia and their carers can access information about current trials.

Factsheet 409

Last updated: November 2010
Last reviewed: November 2010

Reviewed by: Steve Iliffe, Professor of Primary Care for Older People, Associate Director, DeNDRoN National Co-ordinating Centre, Department of Primary Care and Population Sciences, University College London