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Informed Consent

by David W. Golann

If you are going to have surgery or are planning to participate in a research study, you may have lots of forms to sign. One you should pay special attention to is the informed consent form. The term “informed consent” refers to the permission you give to someone else to take action that will affect you, with a clear understanding of the potential risks and benefits of that action for you. In the context of medical practice and research, informed consent requires doctors and researchers both to seek your permission before treating you or enrolling you in a study and to give you the information you need to make rational decisions about the treatment being offered or the study you are being asked to take part in. You must be competent to understand and voluntarily agree to the proposed course of action. In so doing, you are granting your informed consent.

The principle of informed consent is a powerful tool in your hands. Many people think that the primary purpose of informed consent is to protect the hospital from lawsuits or to give the doctor or researcher a green light to go ahead with the procedure, treatment, or study. Informed consent does do these things, but its primary purpose is to give you the opportunity to make decisions about your own medical care. It grants you specific rights as a patient or a research subject. Before you undergo any medical treatment or participate in a research study, there are some important things you should know about informed consent.

Informed consent in clinical practice

The principle of informed consent has long been an ethical foundation of practicing medicine. Only in the last 50 years, however, has it been codified into law. In all 50 states, doctors are legally responsible for informing their patients of the nature, purpose, and risks of a proposed treatment or procedure. But far from being an abstract concept, informed consent is a very practical way for you to take part in your own health care.

Informed consent does not always involve a piece of paper that you have to sign. Oral consent (sometimes known as basic consent) is perhaps the most common kind of informed consent. For this type of consent, a doctor explains to you what he or she is going to do, the reasons for doing it, and any risks that may be involved. A doctor who conducts a blood test or prescribes a medicine, for example, will seek your oral consent. Procedures that require oral consent generally have low risk and are accepted practice.

Just because your doctor seeks your oral consent, however, does not mean that you do not have the right to question or refuse treatment. This can be especially important when a doctor is prescribing a drug. Make your consent informed. Many drugs, including those for arthritis, have the potential to cause serious side effects, and you should be aware of these before you begin taking the drug. If you do not understand how the drug works, how to take the drug, or what its benefits, risks, and possible side effects are, ask your doctor about it.

Written consent, on the other hand, is necessary for most surgeries and invasive diagnostic tests. In these cases, a doctor will present you with a form to sign before performing the procedure. Handing you the form, however, does not fulfill your doctor’s responsibilities. The doctor should also explain to you, in layperson’s terms, the meaning of the form. The American Medical Association (AMA) recommends that doctors, in informing someone of a possible treatment or procedure, discuss the following: the person’s diagnosis; the nature and purpose of the treatment or procedure to be performed and its risks and benefits; any alternative treatments and their risks and benefits; and the risks and benefits of not undergoing any treatment. The form you sign will state these risks and confirm that your doctor has covered them in conversation with you. If your doctor has not covered any of these items to your satisfaction, or if you don’t understand something, ask for more information before you sign. And remember that you always retain the right to refuse the procedure or treatment. You may even change your mind and refuse the treatment or procedure after you have signed the informed consent form.

Doctors are also responsible for making sure, before someone grants either oral or written consent, that the person is competent to give consent. For example, a person with Alzheimer disease, or someone taking a medicine that is necessary but impairs judgment, may be determined to be unable to give consent to a treatment or procedure. In this case, a surrogate decision maker must be consulted. Though each state has slightly different rules as to who can be this surrogate, a person previously appointed by you to be your health-care proxy will always be the first person consulted. In the absence of a designated proxy, there is a hierarchy of surrogate decision makers, usually starting with your spouse and moving on through adult children, parents, and brothers or sisters. If no suitable surrogate can be found, a court-appointed surrogate may be called upon to make decisions for you. Surrogates will try to determine what kind of care you would have wanted. Some people make an “advance directive” that clarifies what kind of care they would want should they ever be unable to make the decision on their own.

Last Reviewed on June 13, 2012

David W. Golann was an Associate Editor at Arthritis Self-Management.

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