The concept of informed consent is rooted in the fundamental ethical principle of the right of self-determination. This principle recognizes that patients are autonomous; that is, that they are independent agents with the capacity to make decisions regarding their well-being without coercion from others. The need to respect an individual's autonomy stems from the work of the 18th-century philosopher Immanuel Kant, but the medical-legal concept of informed consent was first introduced by 3 court cases in the mid 20th century. Salgo v. Trustees of Leland Stanford Hospital (Cal.App.2d 560, 317 P.2d 170 [Sup. Ct. Appl.]), in 1957, determined that the physician is required to explain the risks, benefits, and alternatives of a proposed procedure to a patient. Natanson v. Kline (186 Kan. 393.350 P.2d 1093), in 1960, further specified what information should be disclosed to a patient and introduced the "professional practice standard." This standard requires that a physician disclose to a patient what other physicians in the community would disclose under similar circumstances. In 1972, Canterbury v. Spence (464 F.2d 772 D.C. Cir.) introduced the "reasonable person standard" which requires disclosure of information that a reasonable patient would consider important in making an informed decision.1
The Centers for Medicare & Medicaid Services (CMS), through their Conditions of Participation (CoP), which health care organizations must meet to participate in the Medicare and Medicaid programs, address the issue of informed consent. CMS grants "deemed status" to hospitals accredited by organizations they recognize such as the Joint Commission, ensuring that hospitals meet or exceed the CoPs. In a memo to State Survey Agency Directors dated April 13, 2007, the Center for Medicaid and State Operations/Survey and Certification Group announced revisions to the Hospital Interpretive Guidelines for informed decision making and informed consent. In the Patients' Rights CoP, (42 CFR §482.13(b)(2)), the interpretive guidelines state
Hospitals must utilize an informed consent process that assures patients or their representatives are given the information and disclosures needed to make an informed decision about whether to consent to a procedure, intervention, or type of care that requires consent.
In the Surgical Services CoP (42 CFR 482.51 (b)(2)), the interpretive guidelines state
The primary purpose of the informed consent process for surgical services is to ensure that the patient, or the patient's representative, is provided information necessary to enable him/her to evaluate a proposed surgery before agreeing to the surgery. Typically, this information would include potential short and longer term risks and benefits to the patient of the proposed intervention, including the likelihood of each, based on the available clinical evidence, as informed by the responsible practitioner's professional judgment. Informed consent must be obtained, and the informed consent form must be placed in the patient's medical record, prior to surgery, except in the case of emergency surgery.
The interpretive guidelines further state
It should be noted that there is no specific requirement for informed consent within the regulation at §482.52 governing anesthesia services. However, given that surgical procedures generally entail use of anesthesia, hospitals may wish to consider specifically extending their informed consent policies to include obtaining informed consent for the anesthesia component of the surgical procedure.
Securing a patient's consent for medical treatment is a process requiring effective communication between doctor and patient. Increasing numbers of patients view the doctor-patient relationship as a partnership and expect to be actively engaged in the decision-making processes governing their health care.
There are several elements intrinsic to the informed consent process:
A detailed discussion of the terms competence and capacity is beyond the scope of this article. The term competence refers to a patient's legal authority to make decisions.
Adult patients, generally considered patients who are 18 or older, are presumed legally competent to make health care decisions unless otherwise determined by a court. Consent to treat a minor must be given by a parent or legal guardian unless state law recognizes certain conditions that may qualify as an exception to the general requirement for parental or guardian consent. For example, depending upon the state law, minors may be legally authorized to consent to their own health care if the patient is a parent; is pregnant and consenting for prenatal care; is married; is otherwise emancipated; or is in the active military.
"Capacity" refers to a determination made by medical professionals that a patient has the ability to make a specific decision at a specific time. To have capacity, patients must have the ability to understand and reason about their medical conditions, and to appreciate the indications, risks, benefits, and alternatives to proposed treatments. It is the physician's responsibility to determine if a patient lacks capacity to a reasonable degree of medical certainty. If a patient lacks capacity, consent must be obtained from an authorized decision maker, unless an emergency or other exception applies. State law will govern who will be considered a legally authorized surrogate decision maker. For example, depending on the laws, this person may be a designated health care proxy, spouse, or an adult next-of-kin.
Consider the following example: a healthy adult patient who presents for elective surgery is competent and has capacity to consent for a surgical procedure. The same patient has an unexpected outcome, is in the intensive care unit, intubated and sedated, and requires a second operation. The patient will now not have capacity to consent for the second surgery, requiring the consent discussion to occur between the surgeon and the patient's authorized decision maker.
Obtaining informed consent requires active communication between physician and patient. The communication process is an ethical obligation of the practice of medicine and a legal requirement per statute and case law in all 50 States.2 The goal is to provide the patient with sufficient information to allow him or her to understand the nature of the medical problem; the indications for treatment; the material risks, benefits, and alternatives to treatment; and the consequences of refusing treatment. It is only then that the patient can make an informed choice with respect to suggested therapy. The informed consent discussion should allow a meaningful opportunity to have questions considered and answered.
What constitutes "sufficient information"? Most states use a "reasonable person" standard (see above), although there are some that rely on a "professional practice" standard. The informed consent discussion should focus on the indications for the proposed treatment, a description of the procedure in terms a layperson can understand, and an explanation of available alternatives. A frank disclosure of material risks of the recommended and alternative treatments is important. Material risks are those that a reasonable person would want to be made aware of before deciding to undergo or reject the recommended therapy. Material risks include those that occur commonly, but have little long-term consequence, as well as those that are rare but may result in severe, long-term morbidity or mortality. A recent informal survey of both private and academic institutions across the country revealed that the following "common" risks of general anesthesia are frequently disclosed: possible oral or dental damage, sore throat, hoarseness, postoperative nausea and vomiting, drowsiness, and urinary retention. Disclosure of more severe risks includes possible awareness, postoperative visual loss, aspiration, negative pressure pulmonary edema, organ failure, malignant hyperthermia, drug reactions, and the risk of failure to recover from the anesthetic, coma, or death. For regional anesthetics, common risks often disclosed encompass prolonged numbness, "spinal headache," backache, and failure of the regional technique. Less common but severe risks frequently discussed include bleeding, infection, nerve damage, persistent weakness or numbness, seizures, coma, and death.
Introduction of uncommon, but potentially devastating risks in the holding area, immediately preoperatively, is suboptimal for patients and uncomfortable for anesthesia professionals. This is especially problematic if their surgical colleagues do not habitually disclose specific risks that are known, uncommon, but significant sequelae of certain types of surgeries. Consider the risk of postoperative visual loss that has been associated with major reconstructive spine surgery, cardiac surgery, and extensive ENT procedures. It is conceivable that patients presented with the possibility of sustaining permanent visual impairment for the first time immediately prior to surgery may wish to reconsider or delay their decision to proceed with the proposed treatment. A better approach may be utilization of a standardized, institutional consent process developed by the surgical and anesthesia professionals who routinely care for these patients.
In addition to discussion of risks, benefits, and alternatives, some states require disclosure of the identity of all persons reasonably anticipated to be involved in the patient's anesthetic care. Absent a written informed consent document naming all of the members of the anesthesiology department, this may prove to be problematic.
An important part of the informed consent process is offering the patient one's professional opinion of the best options given the skill set of those providing the anesthesia, knowledge of the patient's comorbities, knowledge of the patient's comorbidities, and the surgeon's preferences. Important to this part of the discussion is an explanation of the pros and cons of the recommended technique as well as the back-up approach. It is important to appreciate the differences between persuasion, manipulation, and coercion in presenting this information to the patient.
Following a discussion of indications for the therapy, disclosure of material risks, benefits, and alternatives, and having questions answered, the patient is in a position to make an informed decision. The patient's authorization to proceed with a proposed course of treatment is an expression of his/her right of self-determination and is the basis for informed consent.
It is important to record the informed consent process in the medical record. Many organizations are adopting a separate, written informed consent document for administration of anesthesia. Some states require this, but there are other reasons to consider using this approach: common risks of all techniques can be clearly detailed; patient-specific risks can be added in longhand; the patient and a witness sign the form; and it allows efficient documentation of the informed consent process for the growing number of patients who require anesthesia for a non-surgical procedure. Other organizations rely on the surgical consent form to document consent to anesthesia. This practice is problematic as the consent document may be completed in the surgeon's office before the patient has an opportunity to talk with an anesthesiologist or nurse anesthetist; reliance on the surgeon to conduct an informed consent discussion for anesthesia presumes that they are as competent as an anesthesia professional to do this. Informed consent for anesthesia should be provided by those who are competent to do so. This important task pertains to a unique scope of practice and should not be delegated to those lacking this specialized knowledge and training.