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Informed Consent as written by a Kaiser Permanente physician and published in eMedicine Journal, October 5 2001, Volume 2, Number 10 © Copyright 2001, eMedicine.com, Inc.
Editor(s): Lanny Garth Close, MD, Chair, Professor, Department of Otolaryngology-Head and Neck Surgery, Columbia University College of Physicians and Surgeons; Francisco Talavera, PharmD, PhD, Senior Pharmacy Editor, eMedicine; Robert M Kellman, MD, Professor and Chair, Department of Otolaryngology and Communication Sciences, State University of New York Upstate Medical University; Christopher L Slack, MD, Consulting Staff, Otolaryngology-Facial Plastic Surgery, Lawnwood Regional Medical Center; and Arlen D Meyers, MD, MBA, Professor, Department of Otolaryngology-Head and Neck Surgery, University of Colorado at Denver and Health Sciences Center
The contributors do not disclose any conflict of interest.
Ideally, legal rules codify important societal and cultural values. The law of informed consent is such a rule. The origins and scope of this rule illuminate the relationship between the physician and the patient.
The requirement that physicians obtain informed consent from their patients before treatment codifies a belief of the predominant Western culture that people have a basic right to control their own lives and bodies.
In California, this principle is enshrined in the state constitution, which states:
All people are by nature free and independent and have inalienable rights. Among these are enjoying and defending life and liberty, acquiring, possessing, and protecting property, and pursuing and obtaining safety, happiness, and privacy.Other states have similar provisions. A right to privacy, confirmed by the Ninth Amendment, also has basis in the US Constitution. Thus, the common phrase the "right to be let alone" has set forth a core value. In 1905, Justice Brown of the Illinois Supreme Court stated:
Under a free government at least, the free citizen's first and greatest right, which underlies all others—the right to the inviolability of his person, in other words, his right to himself—is the subject of universal acquiescence, and this right necessarily forbids a physician or surgeon, however skillful or eminent, who has been asked to examine, diagnose, advise, and prescribe (which are at least the necessary first steps in treatment and care), to violate without permission the bodily integrity of his patient by a major or capital operation, placing him under an anesthetic for that purpose, and operating on him without his consent or knowledge...LACK OF INFORMED CONSENT AS BATTERY
American law initially considered issues of informed consent under the mantle of battery, which considers that any offensive and unconsented touching of another renders a person liable for damages. This law may still apply to patients under anesthesia and dates back to the early days of the Common Law.
Lack of consent is an issue of battery. When active misrepresentation is used to induce consent to surgery, perhaps by exaggeration of the surgeon's experience, the consent is invalid, and battery has taken place. Failure to disclose known adverse effects has been similarly defined. Persuading a court that a consent issue should be judged under the rules of battery may be of critical importance in some jurisdictions because punitive damages may be available for one cause of action and not the other. Statutes of limitations may differ as well.
In states with limitations on noneconomic loss in medical malpractice cases, the ability to seek punitive damages through a battery cause of action may be the only mean to obtain legal assistance (because medical malpractice claims accrue smaller fees for the attorneys).
Currently, issues of consent are rarely prosecuted as battery. Instead, modern informed consent law states that, once a physician-patient relationship exists, a physician has a duty to provide to his or her patient the information needed for the person to make a rational decision whether to undergo surgery or any other treatment or to refuse treatment altogether.
LACK OF INFORMED CONSENT AS NEGLIGENCE
Breach of duty through failure to provide patients with needed information is negligence and, therefore, is part and parcel of the standard medical malpractice claim. Although the law allows withholding information under special circumstances (ie, the therapeutic privilege), in which a patient's family and physician agree that a patient would be harmed by the information, rarely is there reason to invoke it. A physician will rarely want to risk being "second-guessed" after the fact.
If the underlying rationale is that patients should direct their own lives, then a patient who is not a minor or who has not been ruled incompetent by a court cannot justifiably remain uninformed.
Physician arguments that a given patient may refuse necessary treatment and thereby lose a chance of cure generally and rightfully have been disregarded and discarded by the courts. Such arguments presuppose paternalistic authority of the physician to make necessary cost-benefit analyses for the patient. Only the patient can understand his or her own priorities.
To obtain an informed consent that is acceptable to a court and meets ethical obligations, the following information must be provided:
While some physicians make an honest effort to warn patients about risks, they sometimes fail to disclose known adverse effects. That patients realize that surgery requires incisions and that incisions lead to scars is easy to assume. Every facial plastic surgeon has, nevertheless, explained to a skeptical patient that no surgery can be performed without leaving scars and that plastic surgery is the technique of minimizing visible scarring. Some patients just refuse to believe it.
RECURRENT PROBLEMS IN INFORMED CONSENT
Identifying adverse effects
Adverse effects may be well known to physicians; however, it is not safe to assume that patients have this same knowledge. When a suit is filed against a physician for not informing the patient of a particular adverse effect (eg, gustatory sweating after a parotidectomy), the physician may say that the suit is frivolous.
Analysis of suits filed suggests that frivolous suits (ie, suits that are based on complete lack of science) are extremely rare. An example of a frivolous suit may be the well publicized suit filed a few years ago in which a person complained that MRI scans performed after a head injury deprived her of her psychic abilities. However, suits such as impotence resulting after radical prostatectomy or sterility after bilateral oophorectomy are not frivolous if the patient was not warned about these effects prior to the surgery and was unaware that these effects could potentially occur. Patients cannot be held to the same level of medical knowledge as physicians.
What to disclose
The initial formulations of the level of disclosure needed for an informed consent require a physician to make those disclosures that a reasonable medical practitioner would make under the same or similar circumstances.
The disclosures that meet the standard are determined at trial by expert testimony. Under such a rule, which is followed in approximately half of the states, the level of required disclosure is largely determined by local practice.
In some states, decisions regarding informed consent are being incorporated into law. In California, for example, 9 separate procedures have informed-consent requirements, and accompanying state-prepared documents, that must be used if a suit is to be valid.
The rationale of limited disclosure
The courts attempt to further differentiate the risks required to be disclosed by referring to them as material risks. The definition of a material risk is a risk or adverse effect that is important to the patient; information that would affect the decision-making process of a reasonable person. The courts have sometimes quantified risks in the form of a percentage.
Risks that may be trivial but are common and risks that may be rare but are severe must be disclosed. A risk that is severe but rare is the risk of death. That the risk of death be disclosed in all cases seems reasonable; however, many physicians object to such disclosure, stating that everyone knows that the risk of death is present. They emphasize that knowledge of the risk may interfere with physician-patient rapport and patient healing and recovery.
Some physicians and many malpractice defense attorneys object vigorously to "laundry-list" consents. They have support in the law.
The Kansas Supreme Court stated that the requirement for reasonable disclosure "does not mean that a doctor is under an obligation to describe in detail all of the possible consequences of treatment." This may "so alarm the patient that it would...constitute bad medical practice."
The court concluded that, if the physician was "motivated only by the patient's therapeutic best interests," the physician's judgment as to what is disclosed should be respected if it is in agreement with the practices of other physicians in the community.
Usually, defense lawyers argue that a written statement by the physician that "all risks were discussed, all questions answered, and an informed consent given" covers all eventualities. They insist that, no matter what complication or untoward outcome results, the physician can claim that the patient was warned. Conversely, the patient can insist that the complication was never mentioned. The explicit rationale in this instance is that, in such a conflict of assertions, a jury will believe the physician.
The rationale of full disclosure
Otolaryngologists are familiar with the parent or the patient responding with disbelief when they explain that numerous deaths occur in the United States every year from tonsillectomy.
Not everyone knows that tonsillectomy may result in death. Once informed, some patients or parents decide to forego tonsillectomy. For them, even the smallest risk of death is sufficient grounds to delay or avoid elective surgery. Others proceed with surgery, acknowledging the risk.
When such different reactions to the threat of death are observed, attempting to determine which of the numerous other risks or adverse effects would be material to the patient opens the physician to later questioning of his judgment. Furthermore, the same risk or adverse effect that would be dismissed as inconsequential if disclosed prior to the event becomes a major concern after the disaster occurs.
A 10% chance of gustatory sweating is naturally dismissed (preoperatively) when faced with the removal of a potentially malignant pleomorphic adenoma of the parotid gland; however, postoperatively and without warning, this same problem may be elevated to a major social handicap when the pathologist reports a benign lesion.
A patient warned preoperatively that the ear is likely to be permanently numb after parotidectomy may be intensely unhappy but will not sue as a result of the numbness. However, if the patient is informed after surgery that the numbness was expected and is normal, he may well react with disbelief and a conviction that such an explanation is offered merely as an attempt to avoid malpractice litigation.
The simple solution to this is to disclose everything. Those opposed to laundry-list disclosures are appalled by this suggestion. However, both ethical and statistical considerations support the idea of total disclosure.
First, it is not the physician's province to determine what risks or adverse effects each patient considers important. Physicians frequently react with disbelief when patients explain their reasons for refusing a recommended therapy, because they understand how small the risk is in actuality or because the patient's fear is so unrealistic. Yet, patient autonomy means that the values that lead to the patient's decision must be respected.
Second, when the most complete disclosure list possible is created, only the most obscure possibilities are excluded. A conscientiously prepared list excludes only a few risks that are highly unlikely and occur in fewer than 1 per 100,000 cases. Therefore, the chances of such an event both occurring and being absent from the list is much less than 1 per 100,000 cases.
Should the event occur, no jury would likely believe that such a remote possibility was included under the "all risks discussed" umbrella, leaving the physician at the mercy of the jury. In this instance, with an injured patient in the court, the jury would have to decide in retrospect whether the risk was a material one that should have been disclosed. Conversely, the lengths to which the surgeon has gone to inform the patient will make it clear to the jury that every good faith effort was made to convey that information and that this risk was truly unlikely and unpredictable.
Total disclosure is the best technique to avoid second-guessing and postdisaster revisionism.
OBTAINING THE INFORMED CONSENT
The responsibility for informed consent remains with the physician, even though physicians may delegate the duty of educating patients to auxiliary staff, and the auxiliary staff presents the informed consent document to the patient for signature. Therefore, the statement "My nurse forgot to tell Mrs. Smith that voice changes can result from thyroid surgery" is not an acceptable defense to an allegation of failure to disclose that risk.
Informed consent is not a piece of paper with a patient's signature at the bottom. In a nation where a substantial number of adults have limited ability to read, further explanation and teaching must occur before the patient signs the paper. The piece of paper documents a process, just as a signed contract provides written evidence of a process of negotiation that has led to an agreement. The agreement comes before the decision is made to put the agreement in writing. Therefore, informed consent implies patient participation in medical decision making. Enough information must be provided to patients in terms that they can understand to assure that their right to self-determination can be exercised effectively.
Informed consent is implicit in the codes of conduct of medical professional organizations, such as the Principles of Medical Ethics of the American Medical Association.
Ethical care leads to informed consent because it requires a process of providing the patient with the following:
Again, the document signed at the end of this process is merely evidence of the process that preceded the signing.
Informed consent and minors
Generally, minors may not give consent for their own medical care. Both legal precedents and legislation have modified this in many ways. A minor emancipated by a court or through a legal marriage may give consent for care to the same extent as an adult. In most states, special provisions have been made for minors to receive reproductive services. Prescription of birth control medications, fitting of diaphragms, abortion, and labor and delivery services are among the matters covered by such legislation.
Because the rules differ from state to state, any physician engaged in that form of medical practice should seek assistance from a local medical society or experienced attorney to ascertain the local rules before proceeding.
Informed consent and the (possibly) mentally incompetent
No special issues arise when a court of competent jurisdiction has declared a person in need of medical treatment incompetent and has appointed a guardian. The guardian stands in loco parentis and can give consent to the same extent as a parent could give consent for a child and can give consent in place of the incompetent person. A physician, who provides the same informed consent information to the guardian as would have been given to the competent adult, stands on firm legal ground.
However, problems arise when the person in need of treatment has not been declared incompetent beforehand. He or she may be of perfectly sound mind except for the incapacity of the illness at hand. Therefore, the physician is faced with the risk of being questioned not only by courts or family but also by the patient.
When physician and family are in agreement that a particular treatment should be provided, proceeding with the informed consent process with all responsible family members is generally considered safe. When the physician and family do not agree, protection of a court order should be sought if time permits.
As already noted, states are becoming more involved in informed consent matters. In California, specified protocols that effectively prescribe the level of required disclosure must be provided to patients who are about to undergo treatment of breast cancer, prostate cancer, infertility, any surgery in which a blood transfusion is a reasonable possibility, and for other specific instances.
Because the rules differ from state to state, local advice is mandatory. The majority of states publish a handbook for licensed physicians outlining their legal responsibilities in all matters, including informed consent. Every physician should obtain a copy of that handbook in the states where it is available and review it periodically.
In cases in which consent is refused, the physician should obtain an informed refusal from the patient. Failure to inform the patient of the risks of declining treatment renders the physician liable to the same extent as failing to disclose the risks of performing the treatment. Unless the patient knows the risks of leaving the disease or condition untreated, a truly informed decision in which the patient can balance the risks and benefits within the patient's own psychological framework has not been reached.CONCLUSION
An informed consent is a consent that results from an understanding by the patient of the risks and adverse effects of the proposed treatment. Obtaining an informed consent requires that the physician make an effort to educate a patient capable of learning. The physician who makes this effort and obtains such consent has met both the legal and ethical obligations imposed upon him or her by society.