Other Useful NetLinks Handbook Contents Introduction Risk management Insurance program Legal system Medical records Incident reporting Physician-patient Informed consent Infectious disease Confidentiality Patient's rights Risk Home Page

Informed Consent Many physicians feel that informed consent is merely a formality necessary to obtain the patient's signature on a form in order to allow a specific procedure or treatment to be performed on the patient. Rather, informed consent should be thought of as a communication process through which a patient, with the advice and support of his or her physician, makes decisions concerning the treatment he or she will receive. The process assists in developing the critical element of trust between the physician and patient, and is often the most important discussion a physician will have with his or her patient. Patients may bring a claim or lawsuit against the hospital and/or a physician predicated solely on the allegation that they did not give their consent; this is called a battery. A second more common claim is that the consent given was not based upon proper and adequate information; this is known as a claim for "lack of informed consent." This type of claim is usually found as part of the typical malpractice or negligence action. Because of this type of potential claim, from a risk management perspective, the informed consent process plays a crucial role in minimizing the exposure of both the hospital and physicians to medical malpractice claims and lawsuits.   What Is Informed Consent? Informed consent is a three part process in which there is an exchange of information between the physician and patient. The first part is the disclosure and explanation to the patient, in language that the patient can understand, of the nature of a proposed procedure or treatment, its potential risks and benefits, and reasonable alternatives which may be available. The second part of the process involves: 1) ensuring that the patient understands what has been explained to him or her (to the best of the patient's intellectual capacity); 2) the patient accepting the risks; and 3) the patient giving his or her consent to undergo the procedure or treatment. Finally, the process must be documented. In the process noted above, in many instances, the patient will be asked to sign a form acknowledging that he or she has received sufficient information upon which informed consent can be given for the procedure or treatment, and has given his or her voluntary permission to undergo it. Also, the physician who had the discussion with the patient must document the details of the discussion in the patient's medical record. Physicians are responsible for obtaining informed consent. The physician who will perform the proposed procedure or treatment should engage in this process with the patient. It is acceptable for a physician to delegate the task of obtaining the patient's signature on the necessary consent form to another member of the health care team. However, this should occur only after the discussions necessary for a patient to give his or her informed consent have occurred.   What Information Should Be Discussed With The Patient During The Informed Consent Process? Where possible, it is desirable for the informed consent discussion to occur a sufficient period of time before the proposed procedure or treatment in order to allow the patient time to consider the information and ask questions. During the discussion, it is recommended that the physician use language the patient can understand and avoid the use of "medical jargon." The informed consent discussion may take place in the physician's office prior the patient's hospital admission, in the patient's hospital room, and in emergent situations, in the emergency room or other procedure/treatment areas of the hospital. A patient must have capacity in order to give informed consent. This requires that the patient understand the proposed procedure or treatment and be able to voluntarily give or withhold his or her consent after making an informed decision. Informed consent may be given by adult patients with capacity, the parent or legal guardian of a minor, emancipated minors under specific circumstances or a court or patient designated surrogate of a patient without capacity. In some instances, a family surrogate may give consent. The following information should be discussed with the patient and documented in the medical record: The nature of the patient's illness, the diagnosis, the proposed treatment plan and the prognosis. A description of the recommended procedure or treatment, and its purpose. The probable outcome particularly if it is difficult to predict, and the patient's expected post-procedure/treatment course. The most likely risks and side-effects, the potential benefits, as well as the potential complications of the procedure or treatment. (see below) Reasonable alternative methods of treatment or non-treatment including the risks, benefits, complications, and prognosis associated with each alternative or with non-treatment. As a general rule, a physician is required to disclose information to a patient that a reasonably prudent person under similar circumstances would want to know. A physician need not disclose all of the risks or complications which may occur, but should discuss: 1) those commonly associated with the procedure or treatment and having a reasonable chance of occurring; and 2) those which have a small chance of occurring, but which have grave consequences. Less common or remote risks/complications should be discussed with the patient if they are significant to that patient.   How Should the Informed Consent Process Be Documented In The Medical Record? The informed consent process is documented in two separate ways in the medical record. The first way is by obtaining the patient's signature on an appropriate consent form following the necessary disclosure of information upon which a patient can give his or her informed consent. The second way is by documenting the informed consent process in the patient's medical record. This can be an entry in the office records maintained by a physician or by a progress note in the hospital record.   The Consent Form State law and hospital policies and procedures require that written informed consent must be given by all patients before any non-emergency operation, invasive procedure or treatment, regardless of whether that procedure takes place in the operating room, a treatment room or office. The hospital has developed a consent form for surgical operations and diagnostic or other therapeutic procedures, which must be signed by all patients and the responsible physician. These consent forms can be found on all patient units. When questions arise regarding the need for or use of these forms, the Office of Legal Affairs should be consulted.   Entries In The Medical Record The contemporaneous documentation of the informed consent process serves as the foundation for the defense of any subsequent claim by a patient for lack of informed consent. The signature of the patient on a consent form alone is not legally determinative evidence that the patient has given informed consent. Poor or absent documentation will force a physician to testify from recollection about an event which occurred several years previously, which will undermine his or her credibility. In addition, poor or absent documentation may be a significant factor in a patient's attorney's decision to institute a legal action. To reiterate, the physician who had the discussion with the patient must document the details of the discussion in the patient's medical record. The entry in the medical record regarding the informed consent process should describe the information disclosed to the patient. Avoid the use of summary statements such as "The patient was advised of the potential risks/complications of the operation and alternatives" and instead, note at least some of the actual risks, complications and alternatives discussed with the patient. For example, the entry could state that "information regarding the risks, complications and alternatives were discussed with the patient and/or family, including but not limited to ...", followed by the specific information discussed. Note whether the patient was given any booklets or written material regarding the procedure or treatment. It is also important to document any questions asked by the patient and the answers given.