Consent: Giving Informed Consent for Treatment and Research

Mother and daughter signing consent form Mother and daughter signing consent form

What is informed choice or informed consent?

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

Who gives informed consent?

In Ontario, children who are fully capable of understanding have the right to make decisions about their own treatment. Different 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 treatment or 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 treatment 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 treatment 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 treatment or research issues have a right to participate in decisions about their care or participation in research. After having the treatment 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 guardian believe treatment is necessary, treatment will usually be provided. If a child refuses to assent to participate in research, she should not be included in the research.

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

Consent before surgery or other treatment 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, unless your child is capable of deciding him or herself. The doctor (usually a cardiac surgeon or fellow) will discuss with you the risks involved with the surgery, treatment, or procedure under anaesthetic before you sign a consent form. The doctor is required to tell you about any potential problems that could occur and to ensure that you understand the general nature of the procedure. She should also explain why she thinks the surgery is required, and the problems that might occur if the surgery does not go ahead.

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 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 she was 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. In Ontario, 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 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, she 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.

For more information, please read Clinical Trials and Your Child.

Key points

  • Informed choice is the option a person has to allow or not allow something to happen, after she has been informed of the benefits and risks of the options. If the person agrees, she gives informed consent.
  • Different provinces have different rules about who gives informed consent.
  • In Ontario, children who are fully capable of understanding their care have the right to make decisions about their treatment. Children who are partly capable of understanding decisions about their care have the right to participate in those decisions.
  • You have the right to ask questions and express your concerns about treatment.

Christine Harrison, MA, PhD

12/4/2009




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