What Informed Consent Is
A doctor, nurse, or other researcher should always ask your permission to enter you into a clinical trial. They cannot enter you into the trial if you do not give your consent.
There are a few exceptional circumstances where the consent process is different, and people might be entered into a trial without their consent. For example, in a trial of the treatment of head injuries or dementia, an individual may not be able to give their consent. In these cases, consent may be obtained from a relative or other legal representative, and there will be additional safeguards to protect the participants. When clinical trials involve children, the consent process is also different and will be fully explained by the person recruiting to the trial.
To help you decide whether you want to take part in a trial, the researcher should 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, and
what the possible risks and benefits are.
It is important that you are satisfied that you have enough information to decide and to give your informed consent. You should feel free to ask any questions to help 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 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 should be explained to you in your preferred language. You should also be given a consent form that has been written in your preferred language.
The process of informed consent should continue throughout the trial. The researchers should continue to give you information and answer your questions. They should let you know if any new relevant information comes up during the trial so that you can reconsider your decision and withdraw if you want to.
If you decide not to take part in the trial, your decision will be respected, and you do not have to give a reason. You will continue to receive the appropriate medical treatment as needed. Remember, even after you have given your consent, you can leave the trial at any time without giving a reason.