Informed Consent: The Patient's Rights

Risk management for dentists as a formal discipline took shape in the mid-1980s as a result of an enormous increase in the number of malpractice claims. Few dentists were familiar with the basic principles that govern the moral, legal, and ethical standards under which the profession operates. As a result, plaintiffs found an inordinate level of success in their actions. The dental profession responded by providing practitioners with the information necessary to ensure that they could prevent legal complaints and better defend themselves, should they be the subject of litigation.

The vast majority of dentists have always comported themselves with dignity and respect in regard to the doctor/patient relationship. However, dentists required a more sophisticated understanding of the legal process. They needed to understand the appropriate approach to patient communication and how to document patient management. This article addresses but one of a large number of rules that govern the practice of dentistry and the rights and privileges enjoyed by the patients who receive dental care.

INFORMED CONSENT

One of the most imposing and confusing aspects of practice management is informed consent. Practitioners vary in their approach to this process, from doing virtually nothing to satisfy the legal requirements to engaging in a far too lengthy and involved process.

Informed consent focuses on patients’ absolute right to understand their status and the practitioner’s proposed treatment plan. Informed consent is the educational process by which the patient is made aware of the dentist’s diagnosis and treatment plan.

A dentist does not “provide” informed consent to the patient. Rather, the dentist must obtain the informed consent of the patient to perform the intended procedures. This is a process by which the dentist provides certain required information, and the patient is given the opportunity to ask questions and become comfortable with the proposed care, then either refuse treatment or give the dentist permission to proceed. The process is essentially a dialogue in which the situation is discussed until both parties understand the issues and are comfortable with the plan of action.

Failure to obtain informed consent is a departure from the standard of care for dental practice. It is negligent to proceed with the treatment of patients without their approval. If the dentist performs procedures that are not accepted by the patient and some untoward reaction occurs, the dentist can be held liable for the result. While lack of informed consent is rarely the sole basis for action in dental malpractice proceedings, it is frequently one of the claims against the practitioner. The basis for this aspect of an action is the premise that the patient was not adequately informed of the risks of the proposed treatment to be performed by the practitioner. In almost all cases in which a less-than-satisfactory result occurs, it is easy to claim that the potential adverse possibilities were not presented to the patient prior to initiation of treatment. It is inferred that if the patient understood the possible complications, he or she would not have undergone the treatment.

COMPONENTS OF INFORMED CONSENT

The components of the informed consent process are simple and uncomplicated. In fact, almost every time a patient presents for treatment, dentists complete the procedure without acknowledging it as such. Simply stated, it is determining the problem, devising a plan to resolve it, then having a conversation with the patient to define how the anticipated result will be accomplished.

There are 5 basic components of the informed consent process:

(1) Diagnosis of the condition. After performing all of the procedures needed to obtain the diagnosis of the patient’s problem, the dentist is required to present this information in a cogent manner to the patient. Whether it is as simple as stating that there is caries that must be removed and restorations placed or as complex as advanced periodontal disease coupled with endodontic and restorative needs, the dentist must clearly describe the condition.

(2) Recommended treatment plan. Having established the diagnosis, the dentist will develop a primary treatment plan. This should be presented to the patient, discussing the nature of the treatment, the reasons for favoring this approach, and the types of procedures that will be utilized.

(3) Alternative treatment plans. While dentists usually develop a preferred treatment plan, there are almost always other means to achieve an acceptable result. The patient may not wish to proceed with the primary plan, often for financial reasons. The dentist must present all of the acceptable alternatives, regardless of whether he or she is prepared to provide that service personally. For example, many dentists are unfamiliar with and do not provide implant restorative care. Nonetheless, if this is a reasonable solution to the patient’s needs, it must be presented to them as an alternative with the information that a referral to other practitioners would be necessary.

(4) Potential risks of all treatment alternatives. Successful treatment is rarely the basis for a malpractice action. It is only when things do not go as planned that litigation is seen as a remedy by an unsatisfied patient. Every dental procedure is associated with some degree of risk. Endodontic treatment may be unsuccessful or a file might inadvertently be separated within a canal. Bonded restorations may fail or surgical extractions may lead to undesirable postoperative sequelae. It is the responsibility of the dentist to relate to the patient all of the reasonable risks of the treatment to be undertaken so  the patient can make a decision as to whether the expected result is worth the risk. It must be emphasized that only reasonably anticipated risks need to be presented. Case law has supported the fact that undesirable results that are very rare need not be discussed with the patient prior to treatment. Thus, the possibility that a paresthesia might result from the extraction of a mandibular third molar must be presented. However, the occurrence of paresthesia following an inferior alveolar injection is so rarely encountered that it is not necessary to present this as a risk prior to every injection. In a medical case revolving about this principle, the court held that as a matter of law it was not likely that a “reasonable person” would have resisted treatment even knowing of the potential side effect.

(5) Potential risks of no treatment. Sometimes referred to as “informed refusal,” this requires the dentist to inform the patient of the possible risks of not proceeding with the proposed treatment. While dentists generally are concerned about the success of their care and the problems they might encounter, they often neglect to discuss the problems of ignoring a condition. For example, the patient who indicates that they do not wish to undergo endodontic treatment must be told of the potential for infection, pain, loss of the tooth, and the concomitant restorative consequences. The patient who refuses to have an impacted third molar removed should be informed of the problems that might result.

Having presented all of the necessary information, the dentist must now ensure that the patient understands what has been explained. The patient must have the opportunity to ask questions and discuss the issues presented. Only after this dialogue can the patient make the necessary decision regarding treatment, and only then can the dentist proceed with care.

DOCUMENTATION

While this process might seem formidable, it is easy to see that most dentists satisfy all aspects of informed consent in the normal course of patient care. Dentists always tell the patient the nature of the problem, what they plan to do, and the likelihood for success or failure. The reason that this becomes a legal problem is that they neglect to document that the process has occurred.

It is critical to place a notation in the patient’s record that the informed consent process has taken place. Almost all of the claims regarding lack of informed consent would be dismissed if dentists were to pay appropriate attention to documentation. Too often the dentist has a lengthy discussion with a patient during a consultation, then does not record in the patient’s record that the information has been presented or that the proposed treatment was discussed and agreed to by the patient.

As a general principle of good record keeping, a narrative of the diagnosis and treatment plan is required. Statements are needed that the dialogue included discussion of the alternative treatment plans, the potential risks, and that the patient agreed to the plan presented. However, in the case of complex or risky procedures, especially surgical cases, the signature of the patient on a prepared form or following a note in the chart is deemed more desirable. While the use of a printed consent form is not generally required, certain procedures warrant it. Many such forms are commercially available and can be easily obtained.

If a complicated case is presented and discussed, a follow-up letter from the dentist to the patient reviewing the treatment plan and indicating the specifics of the care to be rendered is very useful and will avoid any future misunderstandings. Patients can become confused during an extended and complicated consultation and can often forget what was discussed. Documenting in a letter the issues discussed  is valuable and allows the patient to review the information presented during the consultation at a later date.

Attempting a lengthy consent discussion while the patient is uncomfortable or unable to comprehend the information is not appropriate. The patient who presents with an emergency situation and is in pain cannot be expected to make complicated choices. In addition, it is improper to enter into a dialogue with a patient who is under the influence of nitrous oxide or other sedatives. Decisions made in this situation can easily be challenged in court.

While informed consent is legally required in all cases, the information must be tailored in extent and complexity to the nature of the procedures to be performed. Thus, the discussion regarding the treatment of a periodontal-prosthodontic case will be far more lengthy and involved than one involving simple restorative dentistry. If it is reasonable to believe that patients have a general understanding of the procedures to be performed based on their previous experience, then minimal discussion should be required.

PROBLEM AREAS

The informed consent process presents subtleties and problem areas that must be considered:

(1) In order to obtain informed consent, the patient must be able to understand what is presented by the dentist. Thus, it is imperative that both parties speak the same language, or if that is not possible, that an interpreter be present to assist in the process. Malpractice cases have been lost in which patients claimed that they did not understand what the dentist was going to do because they did not have the ability to communicate. If an interpreter is not present to aid in the discussion, then the treatment must be postponed until it can be explained to the patient. In addition, if the patient is hearing impaired, the dentist should provide the opportunity for discussion either through print or with the aid of an individual capable of signing.

(2) In order to provide consent, the individual must be competent to do so. It is imperative that the dentist be assured that the patient can understand the information provided and is legally entitled to give the permission to proceed with treatment. Thus, individuals who are not responsible for their own actions cannot give consent. Hypothetically, should a dentist choose to treat a mentally impaired individual who has already reached the age of majority in the absence of consent provided by a legal guardian, the risk of a claim of negligence is a possibility. Regardless of how appropriate the care, the treatment should not be rendered. Other examples of individuals who might not be legally capable of giving consent include drug addicts and the elderly who have lost the ability to determine their own well-being and are no longer legally responsible for their interests.

(3) It is obvious that minors cannot give consent for treatment. The dentist should be sure that patients  are of age as delineated in their state before proceeding with care. If a patient is a minor, then the consent must be provided by a parent or legal guardian. Care must be taken when attempting to find a legal representative to ensure that the individual so identified is the appropriate individual. In many states, there are laws that provide rights to people who have not reached the legal age of majority, but have satisfied certain requirements such as being married, having a child, or for some reason are separated from their parents or guardian. These “emancipated minors” inherit the privilege to determine their own needs.

(4) An unusual and rarely encountered situation that would exclude the necessity of obtaining informed consent is “therapeutic privilege.” This is when the provision of the information would be seriously disturbing to the patient, or if it was felt that they would not be able to realistically evaluate the dangers of not proceeding with treatment.

(5) Another exception to the need to obtain informed consent prior to care is where treatment is required in a life-threatening emergency. This type of situation is rare in a dental office and should not be used as an excuse for avoiding the appropriate legal process.

Informed consent is a simple but required component of patient care. Practitioners are loathe to burden patients with too much information, believing that the patients do not want to hear the information and that, if interested, they will ask questions. Many patients tell the dentist they do not want to discuss the proposed treatment because they trust the dentist to do the correct thing and to do it well. It is important to avoid this trap since the patient can fall back on the lack of informed consent as a cause for legal action.

CONCLUSION

Dentists must fulfill the requirements of informed consent as defined by their state laws. The key to success is to communicate openly with the patient, which is also the key to maintaining the type of doctor/patient relationship so important to a successful result. It is essential that the patient understands what is to be done, why it is to be done, and the expected outcome. It is most important that, after spending the time and effort to provide the information and having the dialogue, the dentist documents what has taken place. The perfect process in obtaining informed consent, if not reflected in the patient record, is worthless if the patient chooses to become a plaintiff.

Informed consent is a natural and early component in the development of a fruitful relationship between the dentist and patient. It is imperative that the patient be an active participant in the treatment process. If the patient clearly understands what is to occur and the anticipated outcome, care will proceed in a cooperative setting, and the patient will have realistic expectations.



Dr. Seldin received a DDS degree in 1966 from Columbia University School of Dental and Oral Surgery, where he now serves as associate clinical professor of dentistry. He served as a president of the Dental Society of the state of New York in 1987 and first vice-president of the American Dental Association from 1992 to 1993. He was chairman of the Oversight Committee that produced the ADA’s Future of Dentistry Report in 2001 and presently serves as a national media spokesperson and consumer advisor for the ADA. He has authored numerous articles and has lectured extensively on professional liability and malpractice issues as well as the many social and economic problems currently facing dentistry. Dr. Seldin, who maintains a general practice in New York City, can be reached at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .