Giving consent

No one should ever include you in a clinical trial without asking you. A doctor, nurse or other researcher should always ask your permission, and they cannot enter you into the trial if you do not give your consent.

To help you decide whether you want to take part, the researchers should tell you all about the study:

• what it is trying to find out
• how you will be treated
• what you will have to do.

Various guidelines have been drawn up for researchers, to let them know what information people need in order to decide whether to take part in a clinical trial. But there is a lot of discussion about how much people really want to know and, of course, this varies from person to person.

All that matters is that you are satisfied that you have enough information to make an informed decision. You should feel free to ask any questions that you believe are important 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 before you decide.

The person who suggested that you take part in the trial should first discuss it with you and answer your immediate questions. He or she should be able to give you a patient information leaflet or factsheet about the trial that you can take away and read at your leisure, if you wish. Any alternatives to entering the trial should be discussed with you. You may want to discuss it with your family or friends and consider any practical aspects, such as extra appointments and tests.

If you decide that you wish to take part you may be asked to give your consent verbally to the person carrying out the trial, who will write it in your notes. You will then be asked to sign a form that says that you agree to take part, and the form will be countersigned. You will be given a copy to keep.

If you decide that you do not wish to take part in the trial you can tell the doctor or nurse. Your decision will be respected and you do not have to give a reason. There will be no change in the way that you are treated by the hospital staff and you will be offered the standard treatment for your situation.

Remember that even after you have given your consent you can leave the trial without giving a reason at any time and your doctors will not hold it against you. If you are having a new treatment as part of a trial you may not be able to continue having the new treatment but will be given the appropriate standard treatment for your type of cancer.