Informed consent for brain tumours

PDF download is not available for Arabic and Urdu languages at this time. Please use the browser print function instead

An in-depth discussion of the issue of informed consent for children who are undergoing medical procedures.

Key points

  • Informed choice is the option to allow or not allow something to happen after being informed of all the benefits and risks of all options involved.
  • Agreeing to a specific procedure or treatment is giving informed consent.
  • A parent or guardian usually gives informed consent, unless it is an emergency and the guardian cannot be contacted.

Informed choice is the option a person has to allow or not allow something to happen, like diagnostic procedures or treatment, after they have been informed of the benefits and risks of the options involved. If the person agrees, they give informed consent.

Who gives informed consent?

The principles of informed consent and assent vary greatly from country to country. In many countries, children who are fully capable of understanding have the right to make decisions about their own treatment. Different states or provinces may have different laws about the age at which children can make these decisions. If your child is very young or is not capable of understanding, you, as parent or guardian, give consent for your child to undergo a procedure or treatment or to participate in a research study. If you or your child agree, you or your child will usually sign a consent form.

When the parent or guardian is not available but can be contacted by telephone, a verbal consent is acceptable.

What happens in the event of an emergency?

In the case of an emergency, when a procedure needs to go ahead and the person who should give consent cannot be contacted at all, every reasonable additional effort must be made to contact the parent or guardian. If the procedure cannot wait, the doctor can decide whether to go ahead without consent. This decision is recorded in the patient health record.

What is assent?

Children who are partially able to understand diagnosis, treatment, or research issues have a right to participate in decisions about their care or participation in research. After having the procedure or research explained in a way they can understand, they will be asked for their assent, or agreement, which can involve signing an assent form. If a child refuses to assent to treatment, and the doctor and parent or guardian believes treatment is necessary, treatment will usually be provided. If a child refuses to assent to participate in research, they should not be included in the research.

What does informed consent to undergo treatment such as surgery involve?

Consent before surgery or another procedure is an example of the informed consent process. Before your child is scheduled for a procedure or surgery, you, as the parent or guardian, need to decide whether or not the doctor can go ahead. The doctor will discuss with you the risks involved with the surgery, treatment, or procedure under an anaesthetic before you sign a consent form. They are required to tell you about any potential problems that could occur and to ensure that you understand the general nature of the procedure.

This discussion provides an opportunity to ask any questions you may have about the procedure or express any concerns you have. Brace yourself to hear about the potential negative outcomes. This is usually very difficult to hear, but you should try to stop yourself from thinking the worst.

In the case of surgery and some other procedures, by signing the form you will also be consenting to the use of anaesthetic if necessary. At some hospitals, you may be asked to give a separate consent for the use of an anaesthetic. Usually you are also agreeing to any additional investigation or treatment that the doctor may decide is immediately necessary during the surgery. This would only happen if the doctor finds something they were not expecting to find, and needs to do something about it right away. The consent forms will be kept in your child’s medical record.

What does informed consent to take part in research or a clinical trial involve?

A clinical trial is a type of research study that involves treatment. For brain tumours, a clinical trial compares existing treatment plans to new, potentially better treatment plans. Successes in pediatric oncology (childhood cancer) have been achieved mainly by treating children according to protocols and comparing different protocols in order to improve care.

In many countries, a child that is able to understand fully or partially may decide whether or not to take part in a research study or a clinical trial. The health care team member must make certain you and your child have a full understanding of the purpose of the study, the results expected, how the study works, any risks or benefits, and in the case of a clinical trial, the other treatments available. You may ask questions about the study and receive information about the results when the study is finished.

After explaining this, they will ask you or your child to make a decision about taking part in the study. To give consent to take part, you or your child will sign a document called a consent form describing the research and the risks and benefits to your child.

If you decide not to take part in a research study or clinical trial, your child will continue to receive the same quality of care from your child's health care team and the hospital. If you do decide to take part in the study or trial, signing a consent form is not a contract. You can change your mind and withdraw at any time.

Last updated: July 10th 2009