A doctor, nurse or other research practitioner will always seek your permission to enter you into a clinical trial. They cannot enter you into the trial if you do not voluntarily give your informed consent.
There are a few exceptional circumstances where the consent process is different, and people might be entered into a trial without their initial consent. For example, in a trial of the treatment of stroke or dementia an individual may not be able to give their consent or similarly if a patient is sedated and receiving respiratory support. In these cases, consent may be obtained from a relative or other legal representative and there will be additional safeguards to protect the participants.
To help you decide whether you want to take part in a trial, the researcher will explain:
- the aim of the study – what it is trying to find out
- how you will be treated and what you will need to do
- what the possible risks and benefits are
- how long your participation in the study may last
It is important that you are satisfied that you have been provided with enough information to make a decision to give your informed consent.
You should feel free to ask any questions that are important to you in helping you to reach a decision. You should also feel satisfied that you have been given enough time to think about the trial and what it will mean to you.
The person inviting you to take part in the trial should first discuss the study with you and answer your immediate questions. They should also give you an information leaflet about the trial that you can take away and read in your own time. You may want to discuss it with your family or friends and consider any practical issues, such as extra appointments and tests.
If you decide that you do want to take part you will be asked to sign a consent form that says that you agree to join the trial and that you have decided to do so of your own free will. You will be given a copy of the signed consent form to keep. If English is not your first language, the trial will be explained to you in your preferred language where possible and you will also be given a consent form that has been written in your preferred language.