Obtaining and recording informed consent before major diagnostic, therapeutic, and invasive procedures is a physician’s professional and legal obligation.  Patients have the legal right to grant or withhold informed consent, either personally or through lawful representatives. 

The term “informed consent”, began to be raised in Canada and the United State as early as the 1950s and 1960s.  Courts began to suggest that not only must patients consent to a particular treatment or procedure, but they must do so based on adequate information.  This was formalized by the Supreme Court of Canada in 1980.  A physician could be found negligent if an adverse event occurred of which the patient should have been warned prior to granting consent.  This initiative, hence, provided legal motivation for obtaining and recording informed consent for major treatments and procedures, subject to recognized legal exceptions such as providing emergency medical care to incapacitated patients.  However, in addition to this legal motivation, Council believes physicians ought to be motivated by a commitment to the ethical value of patient self-determination, or personal autonomy. 

The Goal

The goal of offering these guidelines is to help physicians move beyond a limited consent model that emphasizes primarily the physician's legal obligation to disclose information and the patient's legal right to make independent decisions.  Council advocates a different model that emphasizes communication and encourages a certain kind of transaction between patient and physician.  The norms that govern such transactions are clarity, relevance, accuracy, and sincerity.  There is no standard form, nor any uniform procedure that will fit all cases calling for informed consent in this model, but there is an underlying ethical obligation to make it possible for the patient and the physician to participate together in a transaction that takes into account the norms of clarity, relevance, accuracy, and sincerity. 

Shared Decision Making

The primary value of documented informed consent is that it represents the existence of a relationship between physician and patient (hereinafter including lawful representative) that is based upon, or at least includes, an element of shared decision making.  Shared decision making for the patient is not the same as mere acquiescence, or compliance based on partial or slanted information, or indifference due to habit or apathy, nor is it the same as conformity to custom – such as the custom of “following doctor’s orders.” 

Shared decision making is a process for reaching a shared conclusion through informed judgment.  Such a process is an educational ideal in the field of medical care, as it is throughout most institutions in a democratic society.  The heart of the matter is the control of information: to the extent information about a problem can be shared, decisions about potential solutions can be shared.  Physicians have privileged access to medical information through their education, experience, and expertise.  This privilege carries with it the duty to disclose clearly such information as is relevant and is supported by accurate scientific information in a sincere manner for consideration by the patient.  Furthermore, this duty is itself governed by the physician’s fiduciary obligation to protect the patient’s best interests. 

Generally, physicians control the medically relevant information patients need in order to ask the questions they may want to ask but might not be able to formulate on their own.  Successfully sharing that information is a matter of 1) the physician’s willingness to do so, and 2) the physician’s ability to apply the skills of communication required to do so.  It is also a matter of 3) the patient’s willingness to participate in the process, and 4) the patient’s ability to understand the information, apply it to his or her situation, and then express a reasoned judgment based on the relevant medical information as well as on personal values, wishes, and goals.  If there is any doubt about the patient’s ability in this regard, the physician should arrange an evaluation of the patient’s capacity by a qualified colleague.

In a location and atmosphere conducive to thoughtful discussion, the physician personally initiates the process of informing the patient by presenting the medically reasonable options relevant to the patient’s condition.  The medical reasonableness of these options is tied to the available and reliable evidence base of expected benefit and risk for each alternative.  The physician’s judgment about these options should be free of personal self-interest, and religious, political, racial, and gender bias.

Council encourages physicians to remind patients of their right to have someone with them (an advocate of some kind) during these discussions, as patients can be overwhelmed, frightened, and confused when confronting an important medical decision. 

Skills for Eliciting Informed Consent

By far the most important skill is empathetic listening, which is the capacity for acquiring objective knowledge about the perspective taken by another person.  It is a way of listening that requires temporary suspension of one’s personal point of view while trying to assume another’s point of view.  It is a means for gathering data.  It is not synonymous with being compassionate or sympathetic, even though its mere presence can have a beneficial effect.  The primary purpose of empathy in this sense is to become well informed about the patient’s point of view.  It is important for the physician to find out what and how much the patient already knows and what more the patient wishes or needs to know, and to what extent the patient desires to participate in the decision making process.  In disclosing medical information the physician can err in two ways – excess and deficiency.  Empathetic understanding can help guard against going wrong in either of these ways. 

Next is skill in disclosing and explaining.  In trying to establish the basis for shared decision making, the physician discloses medical information relevant to the case at hand, and provides explanations of what that information means, in language that is intelligible to the patient. 

It is important to distinguish between two useful, but distinct, kinds of explanation.  The first is scientific explanation, which is making a case for why certain events are the way they are and for predicting future events.  The second is semantic explanation, which, by contrast, is making the meaning of something clear to the listener.  Semantic explanation is like translation or paraphrase, using different words and terms until the intended meaning is revealed and understood.

An explanation can be satisfactory from a formal (scientific) point of view, while at the same time failing to be satisfying from the patient’s point of view.  Another way to put this point is that, while a medical explanation of risks and benefits associated with treatment options can be scientifically sound, the listener may find it to be unintelligible, and, therefore, not useful as information upon which to grant or withhold consent.  Informed consent depends on the physician’s success in providing both kinds of explanation.

Third is framing.  Anything that can be said, can be said another way.  Decisions are often influenced by the way alternatives are presented.  For example, the outcome statistics for 100 middle-aged men undergoing surgery for lung cancer can be described as “90 survive the surgery . . . and of those 90, 34 are alive at the end of 5 years.”  An alternative way of expressing (framing) the same results might be:  “10 die from surgery. . . and 56 more die within 5 years.” Typically, for a patient choosing between surgery and radiation, surgery appears much less attractive when described using mortality rather than survival statistics.  The difference between 10% mortality (for surgery) and 0% mortality (for radiation) is more impressive than the difference between 90% survival (for surgery) and 100% survival (for radiation).  A physician may knowingly or unwittingly nudge a patient toward one option simply by the way the range of options is described, or framed.  (Note that 5-year mortality statistics for radiation only have not been mentioned.)

Definition of Informed Consent 

In conclusion, Council recommends the following definition of informed consent be adopted and applied by New Brunswick physicians.

Informed consent for treatment has been obtained when:

  1. the physician has disclosed and explained to the patient’s satisfaction the process used to arrive at the medically reasonable and recommended intervention(s), which is based on reliable evidence of expected benefit and risk of each alternative, and which is free of any impermissible bias;

  2. the patient, who has demonstrated capacity, has been given ample opportunity to ask questions about the process and the recommended intervention(s), to the extent the patient wishes, all questions then having been answered to the patient’s satisfaction; and

  3. the patient gives consent in writing to major intervention(s) agreed to jointly with the physician.

Obtaining informed consent is the physician’s personal responsibility.  This responsibility cannot be wholly delegated.  Other staff may usefully participate in the process, but no amount of shared videos, questionnaires, and pamphlets can substitute entirely for personal communicative transaction with the responsible physician.  Finally, proof of informed consent cannot be reduced merely to a signature on a form.  A note from the physician about the process of gaining that signature should be attached to the form.
 

Based on Maine Board of Licensure in Medicine

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