Your clinician and research nurse will discuss the aims of the trial and what is involved. All the possible risks and benefits of taking part will be clearly explained both in person and on paper. As well having a discussion you will be given a patient information sheet which you can take away and read. You may want to discuss it with your family or friends to consider any practical issues.
The principle of informed consent means that if you are thinking of joining a trial you must be given clear information about what the trial is for and what you are agreeing to take part in.
If you decide that you do want to take part you will be asked to sign a consent form to confirm that you agree to join the trial and have decided to do so of your own free will.
A witness may also need to sign the form to confirm this.
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. If appropriate, your family doctor will be told of your participation.
Occasionally, you may be asked to give verbal consent to take part in a research project. In this case your agreement will be recorded in your medical notes by the researcher and confirmed by a witness.
The following clip was filmed at UCLH and includes a discussion between a patient and consultant Professor Jonathan Ledermann about a clinical trial of a new treatment being tested in ovarian cancer. This clip provides a flavour of what types of things might be included in an informed consent discussion. Specific information will vary from trial to trial but important points to note are that the patient had received written information in advance and had had time to think of questions. The informed consent discussion is an important opportunity to have all your questions answered.
You can withdraw from a trial at any point and don’t have to give a reason. You will then have the standard treatment for your type and stage of cancer.
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.
- You may have a new treatment that is only available in a clinical trial
- You may have more check-ups, tests and scans than usual, which you may find reassuring
- You will be helping to improve cancer treatments for future patients
- You may have to make more trips to hospital
- The extra tests and check-ups could increase you worry about cancer
- You may have to do some paperwork
- You may have unexpected side effects from the new treatment
When you join a clinical trial, the research team will need to know certain things about your medical history. This includes blood test and scan results, details of the stage of your cancer and any treatment you have already had. It is important that they know this information. It will help them make sure you are eligible to take part in the trial. And it will mean they can analyse the results more thoroughly.
As with all medical records, this information is confidential. But there are a few people who will need to know you are taking part in a trial.
For safety's sake, the trial team will write to your GP with information about the treatments you are having and possible side effects. The people who care for you at the hospital or clinic will also know. And it will be recorded in your hospital notes. It is up to you whether you tell anyone else.
When you take part in a trial, you have a code number that will be on all the paperwork that relates to you, instead of your name. Your name will not appear in any reports of the results, and no one will be able to identify you from this information.