What you should be told about a clinical trial

This page is about what you must be told before you take part in a clinical trial.  

By law, researchers must explain to you what a trial involves before you agree to take part. You must then sign a statement to say you have been told, and understand, what taking part in the trial means. This is called informed consent. To give informed consent, you must have been told

  • What the trial is trying to find out
  • What treatment you will be asked to have
  • What the likely risks and side effects will be
  • What the benefits may be
  • What tests or check-ups you will be expected to have
  • How often you will be seen in follow up appointments and for how long
  • Whether any of your blood or tissue samples will be kept or used for further research

This information should all be included in the patient information sheet (PIS), or patient information leaflet (PIL). The research team will give you a copy of the PIS to take home and read in your own time. You can refer back to this when you are deciding whether to take part in the trial or not. You can also discuss it with your friends, family, GP, specialist or nurse.

If the trial is investigating a very new treatment, the research team may not know much about the side effects yet. But you should be told everything they do know that is relevant.

You cannot enter a trial without signing your agreement. You are entitled to ask any question you like if there is anything you do not understand.

Good researchers accept that informed consent is an ongoing process throughout the trial. So you should always be able to ask questions, and get answers to them, while you are in the trial.

Remember - you can withdraw from a trial at any time, without giving a reason. You will then be entitled to the standard treatment for your type and stage of cancer.

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Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

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