What is informed consent and what does it involve?

In cases where there are larger possible risks, you may be asked to agree in writing to the doctor's plan for your care. This is informed consent. It recognizes your need to know about a procedure, surgery, or treatment, before you decide whether or not to have it.

It is now common to go through this informed consent process before cancer treatment begins. If you are getting more than one type of treatment for cancer, you will likely need separate informed consents for surgery, chemotherapy, and radiation.

After your first talk with your doctor, you may have only a general idea of your doctor's treatment plan for you. You will likely want to know more so that you can think about the ways this plan may affect your health and your life. In order to freely decide whether the risks are worth the benefits you expect to get from the treatment plan, you must understand the risks and drawbacks of the plan. Most people find that they need to get some questions answered before they can decide on a treatment plan that carries some risk for them.

Informed consent is a process that includes all of these steps:

• You are told (or get information in some way) about the possible risks and benefits of the treatment.
• You are informed of the risks and benefits of other options, including not getting treatment.
• You have the chance to ask questions and get them answered to your satisfaction.
• You have had time (if needed) to discuss the plan with family or advisors.
• You are able to use the information to help make a decision that you think is in your own best interest.
• You share your decision with your doctor or treatment team.

If you have gone through these steps and decide to agree to the treatment or procedure, you are usually asked to sign a paper called a consent form. The completed and signed consent form is a legal document that lets your doctor continue with the treatment plan. The consent form names the procedure or treatment to be done. The rest of the consent form may be very general, stating only that you have been told about the risks of the treatment and other options that are available. Or it may be very specific, outlining in detail what the risks and other options are. Depending on how it is presented, you may sign for one certain procedure or treatment, or you may give blanket approval for any treatments and procedures that the health provider decides are necessary.

From the doctor's viewpoint, informed consent means that:

• A doctor or nurse must make every effort to be sure the patient understands the purpose, benefits, risks, and other options of the test or treatment. Then the doctor or nurse must get the patient's consent before starting. In some cases, even a simple blood test or an injection ("shot") requires written consent from the patient.
• As long as the adult patient is mentally able to make his or her own decisions, medical care cannot begin unless the patient gives informed consent.
• If the patient is a minor (under age), or has a serious mental disability, or cannot give consent, then the parent, legal guardian, or a person authorized by the court must give consent. This is usually a close family member who has reason to know what the patient would want. (See "Who besides the patient can give consent?" in the section "What are the legal requirements of informed consent?") As some very public court cases have shown, an elaborate legal system is in place to guide cases in which the patient is mentally or physically unable to give informed consent for treatment. Such cases may come up if the patient is in a coma (unconscious) or on life-support equipment.

Sometimes health care workers refer to the consent form itself as an "informed consent." This is not quite accurate. Informed consent is the process and actions that take place as you learn about and think about a treatment before you agree to it. Your signature on the form is taken to be evidence that this took place. If you decide that you do not want the procedure or treatment, you would not sign the consent form. In this case, you may be asked to sign an informed refusal form or a form that states you are choosing not to follow medical advice. Your signature on this form implies that you know the risks of refusing, so be sure that you understand these risks and know your other options before you sign. (See the section below, "What if I don't want the treatment being offered?")