Your consent is needed for every procedure or act of care performed by doctors, nurses or other staff. Often this may be implied; for example, you roll up your sleeve so that someone can take your blood pressure. Consent may also be verbal, such as saying ‘yes’ when asked if you agree to a blood test. You may have also be asked for your written consent before an investigation, treatment or operation.
Consent to research is often called informed consent. to do Before you can give your consent, researchers are required:
- To explain the trial to you and provide you with information in writing – a patient information sheet. This should include information about what the treatment is likely to involve, and the benefits and risks. Your doctor should also discuss with you any available alternative treatments. There should be an opportunity to discuss this information. You should be given a copy to keep and refer to later, as necessary
- It is important that you understand the information you have been given – ask questions if you don’t understand or if you want more information
- To give you time to think about joining a study, to talk with your family or friends, your GP or another independent doctor, and to ask questions of the researcher
- To check with you that you understand what has been said
The decision to take part in a trial, or not, is yours. You may say no, or ask for more time to think about it. If you decide to enter a trial, you must give your consent freely and feel that all your concerns and questions have been satisfied.
Whatever you decide, you will be given the best appropriate treatment and care.
The consent form
The researcher will record on a special form that s/he has explained the study to you. You will be asked to sign this form to show that you have given your consent. A witness may also need to sign the form to confirm this. We never accept verbal consent.
You should read the form carefully before signing it and you will be given a copy for reference. Signing a consent form doesn’t affect your legal rights; it’s a record that you agreed to what had been explained to you. A copy of your signed consent form will be kept in your clinical notes and may be scanned to your hospital electronic patient record. If appropriate, your family doctor will be told of your participation.
How long will I have to make up my mind about treatment?
Ask your doctor how long you can take to make up your mind. It is important to remember that once you have made a decision about treatment, you can change your mind at any time, even after you have signed a consent form. Remember, if you decide not to take part in the trial, you will still be given the best appropriate treatment and care.
Can I withdraw from a trial?
After you start receiving treatment or care according to the research protocol you may decide you no longer wish to continue in the trial. You may withdraw your consent to take part in a trial at any time and you don’t have to give a reason. The researcher will discuss your future treatment and care with you.
What if I say ‘no’?
If you decide that you do not wish to take part in the trial, tell the researcher. Your wish will be respected and you will be offered the best available treatment and care for your illness. Your decision to say ‘no’ or change your mind will not affect your care in any way. You will be given the best treatment whatever you decide to do.