Carol was nervous about her upcoming surgery to have her ovaries removed. Her doctor assured her that everything would be fine. When she woke up after surgery, Carol was shocked to learn that the doctor removed her uterus as well.
Carl was suffering from an enlarged prostate. His doctor discussed with him all the treatment options, and Carl decided to undergo a new outpatient procedure that would allow him to avoid surgery while shortening the recovery period. The procedure worked wonders. Carl, however, was upset to learn that while he was under anesthetic, several officials of the company that invented the procedure were allowed into the room to watch the procedure being performed.
In a nutshell, informed consent means that a doctor cannot treat you until he explains the procedure to you and you agree to the treatment. Informed consent protects your freedom to make decisions about your body. It allows you—rather than your doctor—to decide whether to undergo a particular treatment, despite your doctor’s expertise and medical training. With informed consent, the patient makes the decision about treatment—and is the one who has to live with the decision, whatever the outcome.
You might assume that your doctor would automatically inform you of all the options available to you. You must realize that informed consent is, in effect, a dialogue between you and your doctor. It is not simply a piece of paper. Only when you are armed with all available information can you make an informed choice as to your options.
LEARNING THE LINGO
Informed consent: Your agreement to undergo a medical treatment or procedure after your doctor informs you of all the facts needed to make an intelligent decision. It gives you more control over your medical destiny.
Informed consent is the right of all patients, including those who are physically disabled or tourists visiting the United States and immigrants who do not speak English. The law requires that doctors and facilities take steps to ensure that these people are fully informed as to their treatment options before the treatment begins. For example, a deaf person has the right to have someone communicate with her using sign language. If the person does not speak English, an interpreter will usually be used to ensure that the patient understands the illness or injury and the treatment options. The interpreter that is most commonly used today is a phone service that provides interpretation in dozens of languages.
Informed consent came about so patients could better share in decisions about their treatment. One of the earliest cases, in 1914, dealt with a woman who claimed a doctor operated on her, without her consent, to remove a lump from her stomach. The woman sued her doctor and won. As the judge in that case put it: “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in damages” (Schloendorff v. Society of New York Hospital, 105 NE 92, 93 [NY APP 1914]).
Despite the legal requirement that you be informed about all aspects of your treatment, there are still instances, even today, of patients whose rights to consent were violated. A 1995 study by the Food and Drug Administration (FDA) found that dozens of doctors had implanted experimental medical devices in their patients. Those doctors either did not tell the patients the device was being implanted or failed to tell the patients that the device was experimental.
Any implantation of an experimental device is supposed to be discussed with the patient, as well as reported to the FDA. Yet the same study found that in one hospital, doctors implanted an experimental prosthetic device that had a chemical coating in 258 patients, although the doctors reported only 37 of the implantations to the FDA. It is unknown how many of the patients were not told the device was experimental.
YOUR RIGHT TO CHOOSE
Informed consent is not a guarantee of a particular outcome. It is a method of allowing you to make a rational and educated decision regarding medical treatment.
You are properly informed when the doctor explains to you all the facts necessary to make a knowledgeable decision regarding your medical care. This information should be given to you when you are calm, sober, and preferably not medicated. There are times, of course, when you will have to make a fast, nerve-wracking decision about treatment for yourself or a family member. When time is of the essence, the doctor should give you as much information as possible in order for you to make a sound decision, but this information will no doubt be less comprehensive than it would be in other, nonlife-threatening situations.
It is difficult for patients to make rational decisions right after they receive shocking news or when they are under pressure to make a decision quickly. Sometimes a doctor may give you an overview only of the diagnosis and the treatment options in order to let the information sink in and to give you a chance to digest what you’ve learned. Then, at a later time, your doctor will go more in depth into your alternatives. This gives you time to let your head clear so that you can participate more fully in decisions about your medical care.
When you can think clearly, you have to actually understand the information the doctor gives you. If your alternatives are couched in medical jargon that you do not understand, you cannot legally consent to the treatment because, in effect, you have no idea what your doctor is talking about. To be informed, you need to be given the information in terms you can understand. In some cases, a patient will not be able to understand the information, such as when the patient is a child or is mentally incompetent. In those situations, a guardian or a surrogate (someone who is legally authorized to make decisions for you) will need to gather the information and either consent to or refuse the treatment.
LEARNING THE LINGO
Understanding Informed Consent
Informed consent gives you more power in decisions about your medical care, but it also gives you more responsibility. You cannot force your doctor to step outside the boundaries of good medical judgment, to violate medical ethics, or to perform alternative treatment the doctor considers too risky.
You do not have to give informed consent for every medical procedure performed. Informed consent is generally reserved for those situations when:
Regular examinations or the taking of blood samples do not usually require informed consent, unless an HIV test is going to be performed. Informed consent applies to elective procedures, such as plastic surgery and vasectomies, as well.
In most cases on informed consent, the patient consented to the treatment but argues that he did not have enough information about the treatment to make the consent effective.
There are several pieces of information that a patient needs in order to make a choice about treatment:
This does not mean that the doctor has to tell you of every conceivable ache, pain, or minor side effect that may occur. It does mean that the doctor has to tell you about any facts that might cause a reasonable person to decide not to agree to the treatment. For example, a reasonable person might decide to not have surgery after she finds out it carries a 50 percent risk of paralysis. The doctor needs to tell her of this risk in order for her consent to be “informed.”
In most states, a jury will consider four questions to determine whether a patient’s consent was informed.
Even if the patient did not give an informed consent, the patient cannot bring a lawsuit if the patient was not injured. In other words, if there is no harm done, the doctor cannot be punished in a court of law. You are still entitled to file a complaint with the state licensing agency against the doctor for professional misconduct, regardless of whether an injury resulted. The doctor may then face some form of discipline from that agency.
There are several questions you can ask your doctor in order to make sure your consent is informed:
Written informed consent forms vary from doctor to doctor, hospital to hospital. Some are so vague that they seem to cover every imaginable situation that might arise. With forms this vague, many courts have concluded that the patient did not consent at all. Other forms may be so detailed as to inform the patient, for example, as to how bodily tissues or organs will be disposed.
In years past, some doctors and hospitals asked patients to sign a consent form that had patients agree to not sue for malpractice. These forms are of little use today. Courts have ruled that such consent forms are not valid. On the other hand, consent forms that require malpractice claims to be arbitrated are valid. In arbitration, a neutral third party holds a hearing with you and the doctor and then renders a decision. Arbitration is usually much less expensive than a lawsuit because it avoids the formalities and the delays of a courtroom. In other words, they can’t stop you from suing, but you may end up in arbitration rather than a courtroom.
LEARNING THE LINGO
Arbitration: When both sides have an opportunity to be heard by a neutral third party, who then renders a decision by which both parties must abide.
TALKING TO A LAWYER
Losing in Arbitration
Q. If my claim ends up in arbitration and I do not like the outcome, can I still sue?
A. Yes, but your grounds for appeal are very limited.
Answer by Cindy J. Moy, attorney and author, Golden Valley, Minnesota
No. Informed consent does not mean written consent. Informed consent means you have all the information necessary to make an informed decision, regardless of whether you sign a form. Many consent forms are in writing simply to keep in the medical record for the doctor’s and your protection.
No. You are not required by law to sign any kind of consent form. Keep in mind, though, that the doctor can then choose not to treat you. The whole purpose of informed consent is to give you enough information so that you can share in the decisions regarding your health care. Your decision as to whether to sign an informed consent form should be secondary to your decision as to whether you want to agree to the treatment.
No. You have the option to cross out any clauses with which you do not agree or to which you do not consent. Just take a pen and put an “X” through the clause. The doctor must explain the risks of putting those restrictions on the treatment, if any. The doctor may require that the restrictions be noted in your medical record. If the restrictions are so strict as to make the procedure unsound, the doctor can choose to not proceed with the treatment.
There are times when it simply is not possible for a doctor to explain a medical treatment or procedure to you. There are also times when it is not necessary for a doctor to provide you with such information.
Doctors are not required to obtain informed consent from you when:
You can withdraw your consent at any time, but this may affect your treatment. Obviously it is best to change your mind before the doctor begins a surgical procedure. Changing your mind can put both you and your doctor at risk. Once you withdraw your consent, the doctor has to discuss with you the effects of not proceeding with the treatment.
In Wisconsin, a woman went into labor and was admitted to the hospital. She had planned on, and was prepared for, a vaginal delivery. During delivery she changed her mind, and three times asked her doctor to perform a cesarean. The doctor continued to prepare for a vaginal delivery. When complications arose during delivery, the doctor delivered the baby by cesarean section. The baby was paralyzed from the neck down.
The woman sued the doctor because he did not acknowledge that she withdrew her consent to a vaginal delivery. The doctor argued that once the vaginal delivery began, the patient could not withdraw her consent. The woman won the case. Because a cesarean delivery was a viable medical alternative to a vaginal delivery, the woman had the right to withdraw her consent to a vaginal delivery. When she withdrew her consent, the doctor was obligated to discuss with her the consequences of her withdrawal and her options at that point.
Although the woman won in Wisconsin, the law varies from state to state. In every state, though, you have the right to withdraw your consent. Your doctor should discuss with you the effects this will have on your treatment, but the ultimate decision is generally up to you.
After being informed of your diagnosis, as well as of the treatment options and the risks involved, you can choose to not undergo treatment. You can refuse any treatment, as long as you are an adult, unless perhaps you are mentally incompetent and have lost your ability to make informed decisions. Although you have the right to refuse treatment, the public health department has the right to isolate you if you have a contagious disease and are a danger to others. For more on the right to refuse life-sustaining treatment, see the section on Death and Dying (Chapters 26–29).