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.
The exception to these cases occurs when a person is unconscious or otherwise unable to respond, has no available surrogate, and requires emergency treatment. In this case, the doctor must use good judgment to determine what, if any, treatment the person needs. Consent is then considered “implied” or “presumed.”
Informed consent laws were originally formulated after World War II to ensure that people participating in clinical trials were doing so freely and with full knowledge of the treatments being tested. These laws outlined the basic principles — defined later as respect for persons, beneficence, and justice — that govern the treatment of human subjects in clinical trials.
A clinical trial is a research study designed to test the relative effectiveness of a drug or other treatment. Often the trial will compare a new treatment against a standard treatment and/or against a “placebo” (inactive) treatment. Sometimes neither you nor the person administering the treatment will know whether you are receiving the treatment being studied or a placebo. (This is done to eliminate the effects of any bias you, the people giving you the treatment, or the people collecting and evaluating the study data may have concerning the treatment.) Because every study is different, it is important, before agreeing to participate, that you are aware of the study’s procedures and its potential benefits and risks.
You will find this information in the study’s informed consent document. This information should be sufficiently thorough and clear to allow you to make an informed decision about whether to participate in the trial. According to federal law, informed consent documents for research studies must contain the following:
- an affirmation that participation in the study is completely voluntary;
- a statement of the purpose of the study;
- an explanation of the study’s procedures, including how long the study will last;
- a statement of the possible benefits of the treatments offered in the study either for you or for people down the road who may have the same medical condition;
- a list of the possible risks of the treatments used in the study, as well as acknowledgement of the possibility of additional, unexpected risks;
- an explanation of any alternative treatments and procedures that may be beneficial to you;
- an explanation of what treatments are available to you in case of injury;
- contact information for people who can answer questions about the study and explain to you your rights as a study
- an explanation of conditions under which you may be required to leave the study, and an assurance that you can voluntarily stop participating in the study at any time and without penalty;
- a statement describing the confidentiality in which your information will be held.
In detailing the study’s procedure, the form should be very clear about what the study will require of you — that is, when, where, and how you will receive treatment and be monitored, and, if it applies, who will provide your day-to-day care. The form should also let you know who will pay for any costs associated with the study (for example, the price of transportation to and from the study center).
The form may also include other information, such as an explanation of circumstances — for example, new scientific information — that could change the course of the study. The form is also likely to contain detailed information about who will see and what will be done with your information during and after the study. Furthermore, the form is not allowed to deprive you of any right to seek additional compensation for injury that may take place because of the trial.
If you find any of these points not clearly presented, you should ask the researchers basic questions: What will be done to me during the study (and what will I have to do)? How long will the study last? How might I benefit? How could I be hurt? What will happen to my information? Who pays for any expenses that may result from the study? What happens if I am injured in the study, and who pays for my treatment? What if I want to leave the study early? Who can I call if I have a question? The researchers should be able to provide answers to all of these questions.
Remember also that not just any researcher can plan and conduct a study. By federal law, any proposed research study, whether it’s a clinical trial or another type of study, must first gain approval from an Institutional Review Board (IRB). (There are a few specific exceptions, mostly for surveys and observational studies.) IRBs may be set up by hospitals, universities, or for-profit organizations and must consist of a diverse group of at least five people familiar with research practice. To receive IRB approval, a researcher has to present a detailed proposal — called a “protocol” — explaining how the study will be run. Informed consent documents used in the study must also be approved by the IRB.
After the study has been approved, the IRB will set up ways to monitor the study as it goes along to make sure that the protocol is being followed. The researchers are answerable to this board for deviations from the original plan or for any other misconduct. If the study does not follow its protocol, or if the risks of the study become too great, the IRB has the power to suspend or shut down the study. For example, in 2004 new information about the pain-killer celecoxib (Celebrex) and the risk of heart attacks caused one IRB to suspend a study involving the drug (the study was later reactivated). IRBs are an important safeguard against abuse. Make absolutely certain that, if you enter a study designed to test a medical treatment or procedure or a study that takes identifiable information from you, it has received approval from an IRB.
The bottom line
Informed consent carries with it clear ethical and legal responsibilities for doctors and researchers. If a doctor or researcher does not properly inform you of the risks or effects of a procedure, treatment, or study, and you are injured or otherwise adversely affected, it can be considered negligence. But informed consent confers a less obvious responsibility on you — the responsibility to take an active role in your own health care. You are entitled to knowledge, not only of your condition, but also of the ways in which it is being diagnosed and treated. If you do not understand something, ask. The more informed you are about the care you are receiving, the better that care will be for you.