Information and consent

Before deciding if you want to take part in a clinical trial, your doctors will tell you about the treatment and how you will have it.

You should feel comfortable that you have all the information you need and feel able to ask any questions. You may want to talk to your family or friends about the trial before making a decision.

If you decide you want to take part in the trial, you will be asked to sign a consent form. You cannot be entered into a trial without giving your consent.

If you decide not to take part in the trial, you can tell your doctor or nurse. You do not have to give a reason and you will be offered the standard treatment for your type of cancer.

If you give your consent to take part in a trial and then change your mind, you can leave it at any time without giving a reason.

All your medical records are confidential and your name will not be used when the results are published.

Information and giving your consent

A doctor or nurse from your cancer team can explain the possible benefits or risks of joining a trial. They should tell you any other treatments that may be right for your situation.

Before you join a trial, the research team will ask for your permission. They cannot enter you into the trial or do any necessary tests until you give them permission (consent) in writing.

To help you decide, researchers should tell you:

  • what the trial is trying to find out
  • what the trial will involve
  • what you will have to do.

There are guidelines for researchers about the information people need to help them decide about taking part in a trial. But how much information people want to know may be different from person to person. It is important that you have as much information as you need to make an informed decision. You can have a relative or friend with you when you talk to the research team to help you decide. They can help you remember what the researchers said and talk it over with you later.

You should feel able to ask any questions that will help you. It is also important to think about any practical issues that could affect your decisions. For example, this could include:

  • having extra hospital appointments
  • needing different tests
  • having time off work.

We have a list of general and practical questions that you may want to ask.

A nurse or doctor from the research team will give you an information leaflet about the trial. You can take this away and read it in your own time. It can help to talk it over with your family or friends and to think about any practical issues involved.

We have more information about the benefits and risks of clinical trials that may help you.

If you decide you want to take part in the trial, the doctor or nurse from the research team will write it in your notes. They will ask you to sign a consent form saying you agree to take part. Your cancer doctor will also sign it and give you a copy to keep. During the trial, the research team are responsible for your care. They will talk to you about any day-to-day decisions needed for your treatment and care.


Questions to ask

Here are some questions you might like to ask before you decide whether to take part in a trial. Your cancer doctor or nurse will probably answer most of these when they tell you about the trial. Most of them will also be covered in the written information your doctor gives you about the trial.

General questions

  • What is the aim of the trial and how will it help people?
  • What are the treatment choices in the trial?
  • What are the possible benefits of the trial for me?
  • What are the possible risks?
  • How long is the trial expected to last?
  • If I do not take part in the trial, what treatment will I get?
  • Can I withdraw from the trial at any time? (The answer should always be yes.)
  • What happens if I leave the trial early?
  • How long will it be before we know the results of the trial?

Practical questions

You can ask some practical questions to make sure you understand how the trial may affect your day-to-day life:

  • How much time will it take to have the treatment?
  • Will I need extra tests or appointments?
  • Do I have to take time off work?
  • Will I need extra help from family and friends?
  • Will my transport costs to and from the hospital be paid?
  • Do I have to collect the drug from the hospital?
  • Will it involve filling in a questionnaire or keeping a diary?


Confidentiality

If you agree to take part in a trial, your GP will be informed. They are responsible for your day-to-day health at home, so it can help them to know.

Your medical records about the trial are confidential. But your records can be looked at by:

  • people from the drug company involved in the trial
  • the staff who are co-ordinating the trial.

This is to check they are collecting all the necessary information accurately.

No one who looks at your notes can give information to anyone outside the healthcare and research team looking after you. All your information is confidential to the trial research team and your healthcare team.

In the same way, when the results are published, you will not be named.


If you want to leave a trial

Even if you agree to take part in a trial, you can leave at any time. You do not need to give a reason. Before you make the decision, it is a good idea to talk it over with your:

  • cancer doctor
  • specialist nurse
  • research nurse.

This will help them know if there is anything they can do to help you or if there is anything you do not understand.

If you have been having a new treatment as part of a trial, you may not be able to continue with it. But your doctor will give you the standard treatment for the type of cancer you have. By standard treatment, we mean the most effective treatment available now.

If they see that it’s having serious effects and negative effects, they’ll pull you out of it. So you always have the option of stepping back from it.

Tom, clinical trial participant

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