Q.What is informed consent and what does it mean?
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 told about 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 make a decision that you think is in your own best interest.
- You share your decision with your doctor or treatment team.
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 adult patients are mentally able to make their own decisions, medical care cannot begin unless they give informed consent.
- If the patient is a minor (under age), has a serious mental disability, or cannot give consent, then the parent, legal guardian, or a person authorized by the court must give consent before treatment can start. This is usually a close family member who has reason to know what the patient would want.
Q.Why does the doctor need me to sign a consent form?
The main purpose of the informed consent process is to protect the patient. As mentioned earlier, a capable adult cannot be forced to have any type of medical treatment. In general, anything other than a life-threatening emergency in which the patient is unconscious requires consent before treatment. Even in that situation, consent may be required if the patient is known to have an advance directive.
Q.What are the legal requirements of informed consent?
In general, informed consent assumes that you are legally able to make your own decisions. If you are not, the person who is legally allowed to make decisions for you goes through the same process on your behalf.
For informed consent to take place, the information that’s given must be understood. This responsibility is shared by the patient, since the doctor won’t know what you don’t understand unless you ask about it. The patient must have the chance to review the information and ask questions.
And finally, informed consent assumes that when you make your decision, you are not pressured – you freely choose based on what you feel is best for you.
Q.Who besides the patient is allowed to consent?
For children or others who are unable to make the decision for themselves, the parent or legal guardian is legally responsible for getting the information, making the decision, and signing the consent form. But that doesn’t mean that the child or patient who is not considered mentally competent is always left out of the process. Some facilities require the assent of older children. Assent means that, even though the parents sign the form, the child must also be OK with the plan before the facility will do the treatment.
Along the same lines, people who are unable to manage their daily affairs because of impaired thinking or emotional problems might still be able to understand the medical situation and make their wishes known. They should be given information in a way they can understand, and asked what they want to do.
Q.Are there times when the usual consent requirements do not apply?
In an emergency:
- If a person is unconscious and in danger of death or other serious outcome if medical care is not given right away, informed consent may not be required before treatment.
- If those who are giving treatment know that the patient has an advance directive refusing the care, the treatment may not be given.
- If those treating the person know that he or she has an advance directive that appoints someone else to make decisions, that person may be called for informed consent if there is time. But in general, emergency situations don’t allow much time to check on advance directives.
Q.How will I be given information for informed consent?
Methods, such as videos, audio files, interactive computer modules, booklets, and fact sheets, may be used by your doctor or facility to make the information easier to understand. The most important thing is that you understand and are allowed to get answers to your questions, so that you have all the information you need as you consider your decision.
Q.What if I am having trouble understanding the information?
It’s your job to be sure that you understand the information you’ve been given, even if it means going over the information many times.
Sometimes health care workers use words that are hard to understand. Ask the doctor to define words and explain terms. Be sure to tell them what you understand and what you don’t. Sometimes it helps to have a nurse with you. They may be able to re-phrase and explain things in ways that are clearer to you.
If you are facing an important health decision, it may help to bring a spouse, relative, or friend with you. That way, there’s a second listener to help process the information and ask questions.
Q.How long does the informed consent process take?
The entire informed consent process can take place in one short visit for a fairly simple procedure about which you have few questions.
Q.Can I change my mind after I’ve signed the consent?
You can change your mind at any time, even if you’ve already started treatment. Most consent forms say that you also have the right to stop treatment or withdraw even after you have signed a consent form. Even if the form does not mention it, you still have this right. You would need to contact the doctor in charge of your treatment. You may be asked to sign a form refusing further treatment so that the doctor or facility will have a legal record of this.
Q.What if I want my doctor to make the decisions about my care, and I don’t want more information?
Some people prefer not to know a great deal about their diagnosis or treatment. Just as you have a right to informed consent, you have a right to refuse information. Or you can ask for only minimal information and trust your health provider to make decisions for you. At the same time, informed consent laws do not allow a health provider to keep a diagnosis from the patient, even at the family’s request. If you wish to refuse information in today’s legal environment, a wise health care provider may require you to put that in writing.