Volunteering for research into dementia

A great deal of research is currently being carried out into the causes of dementia, diagnosis and treatments. The progress that is being made is only possible because people with dementia and their carers are willing to participate in research.

Range of 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.

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

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.

Consent

Consent must be obtained from the person with dementia before any research is carried out, even if it is simply a question of an extra blood sample. The carer's agreement is not sufficient.

Consent must be adequately informed and voluntary. The person with dementia must be aware of the purpose of the research and what is involved.

The person with dementia 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 family or GP. It should be made clear that even if they do agree to participate they are free to change their mind and withdraw at any point.

The person with dementia should also be reassured that any support or services they receive will not be affected by whether or not they agree to take part in research.

The person with dementia should, in most cases, be given an information sheet giving details of the research and the name, address and telephone number of the researcher and their supervisor. If they agree to take part in the research they will usually be asked to sign a consent form.

Unable to consent?

People with dementia will sometimes be included in a research project even though they are not able to give their informed consent. This can only happen if the doctor concerned believes that the research will be of direct benefit to the person with dementia, and should only happen with the assent of the person's next of kin or a nominated guardian.

People with dementia who are not able to give informed consent should only be considered for participation in research studies if:

It can be shown that important information that may benefit people with dementia in the future cannot be gained in any other way and
There is almost no risk for the person concerned.

Although the decision to include someone with dementia in research without obtaining their consent can only be made by the doctor, relatives should, of course, be consulted and should have the opportunity to review the information. Participation of the person with dementia should only happen with assent from the next of kin.

Research ethics committees

All research undertaken by doctors and other health professionals that involves human subjects must be approved by a research ethics committee.

Research ethics 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 involving people with dementia will go through a research ethics committee, all researchers should make every effort to preserve high standards.

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.

The effects of the new treatment would be very difficult to measure without such comparisons. 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.

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 one of the control group.
'Double blind' means that those carrying out the research do not know which participants are receiving the treatment and which are controls. Because of this their observations are less likely to be biased.

People with dementia should be told that if they agree to participate in randomised trials 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.

Checklist of questions

Before taking part in any research, the person with dementia and their carer should consider the following points:

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 the 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 questionnaires 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?

Complaints

If you have any worries or complaints about the research take it up with the person in charge. If you are still not satisfied seek advice from the Alzheimer's Society or your local advice agency.

Alzheimer's Society