Informed Consent

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What are the legal requirements of informed consent?

States have developed informed consent laws to govern certain types of communication between health providers and patients. These laws list the types of information that patients must be given so they can make an informed decision about having medical care, diagnostic tests, or treatment.

These laws apply to doctors and sometimes to nurses. They vary from state to state. Some states have very specific laws about certain situations. For instance, some states dictate certain information be given about breast cancer treatment or for clinical trials (scientific studies of promising new treatments). Another difference is that some states call only for “reasonable” information; but others require “full and complete disclosure.” (Disclosure means making information known.) If you want to check with your state to find out more about the laws where you live, see the section called “How can I find out more?”

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 (see “Who besides the patient is allowed to consent?” below).

For informed consent to take place, the information that is 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 consider 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.

Informed consent for a clinical trial is usually required to be more detailed and thorough than consent for a standard medical procedure or treatment. This is because there’s a bigger chance of unknown effects with new treatments, and it’s even more important that you know about these possibilities. (See the section, “How is informed consent for a clinical trial or research study different from consent for standard treatment?”)

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 before they go into a research study, even after the parents have agreed on the child’s behalf. Assent means that, even though the parents sign the form, the child must also be OK with it before the facility will do the treatment.

Along the same lines, people who are unable to manage their daily affairs due to impaired thinking or emotional problems may 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.

In the event that you become unable to take in information and make your wishes known, another person may be asked to take part in the process of informed consent. There are several ways that person can be chosen. The only way you can choose the person to make these decisions for you is to set up a durable power of attorney for health care (also called a health care power of attorney). In this case, if you are unable to speak for yourself, the person you chose becomes legally responsible for making medical decisions on your behalf. This person is sometimes called your proxy, agent, or surrogate. A few states restrict the ability of your proxy to carry out certain requests. For more on health care powers of attorney, see our information, Advance Directives. (You can read it on our Web site, or you can call us for a copy.)

Another option is a court-appointed surrogate or proxy. This is someone a judge chooses to make medical decisions for you. If you become unable to make decisions for yourself, someone else – such as the doctor, facility, a friend, or a family member – may ask (petition) the court to appoint someone to do it for you. The process varies from state to state.

Many states have passed family agency acts that choose which family members (in a listed order of priority) may act on behalf of a person who cannot speak for her- or himself. This option may be used if you don’t have an advance directive or court-appointed proxy. Depending on your family situation and which state you are in, that person may be your legal guardian, spouse, parent, child, sibling, or other relative.

Are there times when the usual consent requirements do not apply?

In general, those who make decisions must be legally recognized as adults in the state where treatment is given. But there are a few times when an older teen (for instance, one who is self-supporting and doesn’t live at home, is married, or in the military) does not need parental consent for procedures or treatments. There are also some situations where teens can consent for certain kinds of treatment even if they are underage. The rules and treatment situations vary from state to state.

There are also times when the decision made by the parent or guardian of a child or an incompetent adult may be challenged by the doctor or facility. In these cases, the courts may overrule the usual decision-maker if they think the decision that was made would cause undue harm. But these cases are fairly rare.

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.

Last Medical Review: 07/27/2012
Last Revised: 07/27/2012