Ethical dilemmas exist in medicine when there is more than one possible solution to a problem and those solutions are incompatible with each other. Where there are ethical dilemmas “moral obligations demand … that a person adopt each of two (or more) alternative but incompatible actions” (1). One method for solving these ethical dilemmas, and the one adopted commonly by the western medical community, is to use the framework of the four prima facie principles of principle-based ethics: Autonomy (patient choice), beneficence (do good, prevent harm, remove harm), non-maleficence (do no harm), and justice (treat like cases alike) (1) and weigh their relative merits in each situation (2).

Obstetric anesthesiologists will encounter ethical and legal challenges in their anesthetic practice. In obstetrics there may be several competing interests: The obstetric caregivers, the woman herself, and the fetus. Ethical challenges may result from a conflict between the woman and anesthesiologist, who may have opposing views as to what is best for the woman and her fetus. This results in a conflict between the ethical principle of beneficence and possibly non-maleficence (by the physician) and the ethical principle of autonomy (the woman’s right to choose).

The most common legal and ethical challenge the obstetrical anesthesiologist will face in day-to-day practice will be informed consent. Informed consent is the legal method by which society enforces respect for the ethical principle of patient autonomy. The principle of patient autonomy is relatively new and has replaced the centuries old paternalistic approach of the physician who decided what was best for the patient (2,3,4,5). Informed consent involves recognition that the patient has a choice as to whether or not to accept the recommended treatment.

Honoring patient autonomy demonstrates respect for the patient and her beliefs and this process involves more than following a list of informed consent requirements (Table 41-1). Although these elements are essential there may be other factors involved. For example, a woman may come from a different cultural background where the husband or other family members may be the decision maker(s) (6). The physician must be certain that the woman wants someone else to make her decision (7) and this is best done by talking with the woman in the absence of the family and, if there is a language barrier, using an impartial interpreter (6). If the physician is satisfied that the woman agrees to an alternate decision maker then the physician should respect and work with that decision maker. The act of appointing someone else to make a decision is in itself the exercise of autonomy (1). Autonomous choice is a right—not a duty of patients (1). As not all women from a particular culture follow the same rules, the physician has to recognize that belonging to a particular culture does not mean that everyone from that culture follows all or any particular rule.

To understand informed consent is first to understand that the requirements and the legal remedies for the “informed” part of informed consent differ from the “consent” part of informed consent. To avoid confusion some authors advocate the use of two separate terms such as “consent” and “informed choice” (or “informed decision”) instead of the phrase “informed consent” (8). However, “informed consent” is fully embedded in western society and the terminology is unlikely to change (9).

The requirement for consent has long been part of the common law. Touching another (other than in an emergency or in normal societal living) without consent is a battery (in some jurisdictions called an assault or trespass to the person) for which damages can be awarded even if there has been no injury. As Justice Cardozo put it almost a 100 years ago, “every human being of adult years has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages” (10).

Consent can be implied when the patient cooperates with a procedure, for example, putting up one’s arm for a vaccination implies consent to be vaccinated (11,12). Consent can be given with restrictions. Conversely, a battery can be committed even where an initial consent for the procedure was obtained. Examples of this are:

The patient must have capacity in order to give consent. If consent is not given voluntarily then there is no consent and any resultant procedure is a battery. The voluntariness of the consent can be affected by undue influence (usually when consent is sought by a person in a position of authority). Coercion is a form of undue influence that carries with it a threat (overt or implied). Other influences, such as opinions or recommendations from their physician, family, and/or friends, can impact on the patient’s decision-making process in giving consent. Provided these influences do not control her decision (and seldom will they), the patient’s consent is considered voluntary. There can be no intentional misrepresentation or fraud in obtaining consent. If there is and the procedure goes ahead it is a battery.

Consent does not make a morally wrong act ethically acceptable nor does it make a legally prohibited act lawful. Female circumcision is legally prohibited in most nations as well as considered a morally wrong act. Where female circumcision is legally prohibited consent does not change that legal prohibition nor make it morally right.

The requirement for the informed part of informed consent is a relatively recent development in the law. The American judges in the Nuremberg trials of Nazi doctors in 1948 developed the Nuremberg Code to govern human participation in research. Section 1 of the Code in part says: The subject should be advised of the “nature, duration and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation …” (15).

The words “informed consent” were not used, but in essence Section 1 of the Nuremberg Code recognized the importance of the “informed” requirement for consent (15). In the 1950s the courts began to recognize this principle for health care (16). However, it was only in the last 40 years that the informed part of informed consent, as we know it today, became firmly embedded in the law in the United States and Canada (17,18). The practical reason for the informed part of informed consent was succinctly put by Justice Robinson in Canterbury v. Spence in 1972.

“True consent to what happens to one’s self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each. The average patient has little or no understanding of the medical arts, and ordinarily has only his physician to whom he can look for enlightenment with which to reach an intelligent decision” (17).

Where there has not been consistency is in determining what standard of care is required for disclosure of information. The main standards are the physician standard where the required disclosure is what a reasonable physician in the same field would tell a patient (19) and the objective patient standard where the test is what a reasonable patient in the patient’s circumstances would want to know (17) (Table 41-2).

Approximately half of the states in the United States (20) as well as Canada (18) have adopted the “objective patient” standard with the other half of the states choosing the physician standard (20). A few states have the “subjective patient standard” defined as what information would that particular patient want (20) but almost all of the states and Canada were concerned that setting a subjective standard for disclosure would be unfair to a physician (17,18).

The basis for the objective patient standard rather than the physician standard is the argument that physicians should not set the standard of disclosure, as it is the patient’s need for information that is the governing principle (17,18). The objective patient standard requires that “The scope of the physician’s communications to the patient then must be measured by the patient’s need, and that need is the information material to the decision” (17). However, in some jurisdictions a physician’s personal knowledge of the patient may indicate additional information is required.

The determination of what in any circumstance is a risk that must be disclosed has been an ongoing challenge for both courts and physicians, whatever the standard, but particularly when using the objective patient standard. The governing principle is that the patient should have the necessary information to make an informed decision (Table 41-3). That information includes risks material to the decision and are those risks which a reasonable person in the patient’s circumstances would want to know. If the patient has personal knowledge of risks that the physician fails to disclose (whatever standard) the patient cannot later successfully sue on the basis that the physician failed to disclose those risks.

Whatever method is used to impart the information about the procedure and whomever may be tasked to impart this information, the ultimate responsibility for informed consent lies with the person performing the procedure. The anesthesiologist may delegate the consenting process to a nurse or resident but the anesthesiologist caring for the patient still remains responsible (21,22).

In order to give consent the patient must have capacity. If the pregnant woman has capacity no one else’s consent is required, including that of the husband. Some jurisdictions may require that a third party consent for underage (minor) patients (23). If the patient lacks capacity to give consent, and there is no consent from a substitute decision maker, it is a battery if the physician performs the procedure (unless it is an emergency). Capacity only goes to the proposed medical treatment. A patient may have no knowledge of world events but if she can understand “the nature and purpose of the treatment and the reasonably foreseeable consequences of giving or refusing consent then she is capable” (5). In most jurisdictions there is a legal presumption of capacity for the purposes of consenting or refusing consent to health care (24). A modern proviso to this is the requirement that the patient understands that the proposed treatment applies to her situation. Refusal of a recommended treatment by a patient is not proof of incapacity (25). The use of the words competence, capacity, and capability can sometimes be confusing. Often competency is considered a legal term as in “now that she is 18 years old she is legally competent to make her own decisions.” The American Society of Anesthesiologists (ASA) in their Manual on Professional Liability define competence as “a patient’s legal authority to make decisions” and capacity as “a determination (made by medical professionals) that patient has the ability to make a specific decision at a specific time” (26). The Oxford Dictionary of Current English defines “capacity” as “legal competence” and defines “capability” as “ability, power” (27). The important consideration is that whatever label is used in obtaining consent, it applies solely to the patient’s mental ability at that time to give or refuse consent to that particular procedure. Pain or pain medication does not affect necessarily the woman’s ability to fulfill the legal requirements for consent (28,29).

Part of the requirement to successfully obtain informed consent is to take reasonable steps to ensure that the patient understands the information provided (30). This is particularly so when the patient has apparent comprehension problems, such as those that may arise from language difficulties (30). Providing the information by way of a booklet or a video does not resolve the physician’s obligation to be reasonably satisfied that the information is understood nor does asking the patient if she has any questions on the booklet or video (31). One way to test for comprehension is to ask the patient to repeat back in her own words what has been said to her.

An appreciation of the ethical principle of respect for autonomy is helpful in meeting the legal requirement of obtaining informed consent. When the physician wants to be reasonably certain (whatever standard) that the patient knows and understands the risks, benefits, and alternatives to a proposed procedure and understands that the patient cannot exercise her autonomy without that knowledge, the requirements for informed consent become clear.

If the patient lacks capacity (and depending on state law this can include being a minor) to give consent then the physician cannot act, except in an emergency, and must obtain consent from a legally authorized third party or substitute decision maker (32). Who can be a substitute decision maker will depend on the law of the jurisdiction in which the procedure is to be done. Ways in which it can be done include by state statute authorizing a person (generally on the basis of relationship) to be the decision maker, through proxy advance directives and by medical or durable powers of attorney. The substitute decision maker is not free to apply his or her values to health care decision making for the incapable patient. Any decision is first based on the patient’s known preferences (substitute judgment) and if they’re not known then on the patient’s best interests (what a reasonable person in that patient’s circumstances would decide) (3). Proxy advance directives and powers of attorney for substitute medical decision making are valid only if the legal requirements for their creation are met. If there is no statutory or other legal provision for a substitute decision maker then a court order is usually necessary to either authorize the procedure or to appoint a substitute decision maker.

Informed consent has nothing to do with whether or not the physician carrying out the medical procedure has met the required standard of care. An action for negligence in carrying out a medical procedure is separate and apart from an action for failure to obtain informed consent. The physician can carry out the procedure without negligence but could be found liable for damages if informed consent was not obtained.

Courts in the United States and Canada have been consistent in holding as a policy decision that the failure to obtain the informed part of informed consent is negligence, but not a battery. The same requirements that a patient must show in an action alleging negligence against a physician in carrying out a medical procedure are also required in an action alleging a physician failed to properly “inform” a patient (17,18) (Table 41-4).