Is a legal concept that provides that a person has a right to know the potential?

Elements of Informed Consent

Informed consent refers to the process by which a patient and medical provider discuss a proposed medical treatment, its anticipated consequences, potential risks and benefits, and alternatives. This process allows for open discussion between the provider and the patient and may theoretically help reduce medical errors, improve patient outcomes, and increase patient empowerment (Cordasco, 2013).

A comprehensive informed consent consists of four basic elements: (1) description of the clinical problem, the proposed treatment, and alternatives including no treatment; (2) discussion of the risks and benefits of the proposed treatment with comparisons to the risks and benefits of alternatives, and discussion of medical/clinical uncertainties regarding the proposed treatment; (3) assessment of the patient's understanding of the information provided by the medical provider; and (4) solicitation of the patient's preference and consent for treatment (Cordasco, 2013).

The extent of information to be provided is generally based on the physician's assessment of what information may impact diagnosis and treatment planning. Extraneous information that is unlikely to impact the patient's decision may be withheld. Additionally, to the extent possible, information should be provided in a way that is understandable to the average layperson and facilitates his or her meaningful participation in treatment planning. By discussing options before making a recommendation, the surgeon may reduce undue influence on the patient's decision (McCullough et al., 1986).

To ensure adequate information for consent, patients must understand the “material risks” and expected benefits of treatment. However, there is no clear consensus on what constitutes a material risk. Some have proposed a 1% risk cutoff, with lower risk considered based on the severity of harm (Adams and Smith, 2001). Additionally, there are several limitations to patient understanding of risks. First, patients often use shortcuts to simplify the decision-making process, often leading to misunderstanding of the risks posed by a treatment (Lloyd, 2001). Second, patients may underestimate their own risks compared with other people's (Weinstein, 1989). Third, patients are influenced by the way in which risks are presented (e.g., likelihood of survival versus likelihood of death) (Lloyd, 2001). Counterintuitively, information about clinical uncertainty in the probability of risk improves understanding of risk and also elicits more trust in the information provided (Johnson and Slovic, 1995).

Patients often idealize surgeons and accept surgical recommendations without meaningful participation in the decision-making process (McNeally and Martin, 2000). As a result, the surgeon has a heightened responsibility to solicit patient feedback during the consent process. By empowering the patient to both ask questions and to authorize surgical intervention, the surgeon also strengthens their relationship with the patient, opening the door to an ongoing process of communication before, during, and after treatment (Jones et al., 2007). Substantively, the physician should ensure that the patient understands the goals of treatment, the general nature of the procedure to be performed, as well as expected outcomes including what to expect in the immediate postoperative period.

Abstract

Informed consent can be described as permission given by an individual or someone acting on behalf of another individual for a procedure or set of procedures in clinical medicine or in clinical research. The practice of obtaining informed consent for research participation comes more from the courts than from clinical medicine. Practically speaking, informed consent is a 20th-century legal construct that has been incorporated into medical and medical research practice. Scholars looking for historical evidence of informed consent find it in 18th- and 19th-century clinical medicine (for an expanded historical account of informed consent, see Faden et al., 1986). Where such evidence exists, it is weak and demonstrates an ethical basis for informed consent different from that which exists in both clinical research and medicine up to the 20th century. In clinical medicine, considerations of disclosure and honesty grew from a concept of beneficence, whereas the courts shaped contemporary notions of consent as a right of self-determination. In clinical research, informed consent comes most clearly out of the research atrocities of World War II and the Nuremberg Code.

Informed Consent and Decision Aids

One general approach to ethical reasoning is that ofprinciplism, deploying the ethical principles, or guides for clinical ethical judgment and action, of respect for autonomy, beneficence, nonmaleficence, and justice. Respect for autonomy, which has roots in 18th-century medical ethics, emphasizes the role of patient in self-determination, especially informed consent, shared decision making (SDM), and advance care planning. As a consequence, respect for autonomy is often regarded as the most important ethical principle.

Informed consent is often reduced to the verb,to consent (a patient consents). The nuances of the conversations that should take place with patients are difficult to master for clinicians and can become time-consuming when caring for patients with complex heart disease but are often relegated to junior staff or extenders. The goal of informed consent is to empower the patient with clinical information relevant to the decision at hand and to support the patient in making a voluntary decision, that is, a decision free of controlling internal influences (e.g., unreasoning fear) and external influences (e.g., well-meaning family members who attempt to usurp the patient's decision-making role). Informed consent has four requirements: (1) a patient with decision-making capacity (or their surrogate), (2) a discussion of relevant facts about the medically reasonable alternatives for managing the patient's condition (i.e., alternatives supported in evidence-based clinical judgment), (3) a determination of the patient's understanding, and (4) a voluntary decision. What constitutes “relevant facts” was established with the “reasonable patient standard” in the 1972Canterbury v. Spence case. This standard requires the physician to provide information that any patient with a specific condition, such as stage C heart failure, needs to know. This is a patient-oriented standard and is the legal standard in the majority of the states in the United States. However, ameaningful informed consent additionally should include probable outcomes based on the main risks and benefits of the proposed intervention or procedure in that specific patientand a discussion about the patient's preferences. These would be relevant facts for the patient.

Although the accepted legal and ethical standard of practice, informed consent continues to be poorly done and is heavily biased by physician time and preference.4 The common practice of “discussing” an angiographic finding while a patient is in the cardiac catheterization laboratory and making the decision to intervene is far from ideal; the practical constraints of time often interfere in many settings, as when it would otherwise be reasonable to perform a staged coronary intervention. In some settings, such as emergency care that often includes the presentation of an acute coronary syndrome or aborted sudden death, clinicians practice under the guise of “presumed consent,” and the best interest standard applies to medical care. This standard is based on the ethical principle ofbeneficence, which creates the ethical obligation to provide clinical management that is expected in evidence-based clinical judgment to result in net clinical benefit for the patient.

Conclusions

Informed consent is a process, not a form, and should involve ongoing, interactive dialog between research staff and prospective participants (Institute of Medicine, 2002; NBAC, 2001). Genomic research presents challenges for traditional models of informed consent, and provides opportunities for new models of consent and communication (Beskow et al., 2010a; Mascalzoni et al., 2008). The focus of any consent process should be on informing and protecting research participants, through disclosure and discussion of relevant information, meaningful efforts to promote participants’ understanding, and by ensuring that decisions to participate, or to continue participating, are always made voluntarily.

Informed Consent, Patient-Procedure Verification, and Partner's Presence

Before initiation of neuraxial anesthesia, a preprocedural verification process (i.e., “time-out”) is performed in compliance with national patient safety recommendations. The participation of the patient, the anesthesia care provider, and a third party such as a member of the nursing staff may lead to the discovery of concerns that should be addressed before the initiation of neuraxial anesthesia. The risk associated with neuraxial procedures relates to (1) the physical instrumentation of the spinal axis and (2) physiologic changes associated with medication administration via this anatomic route. Contraindications to needle or catheter placement include patient refusal or inability to cooperate, ongoing bleeding diathesis, infection either at the site of intended intervention or untreated systemic blood-borne illness, and increased intracranial pressure predisposing to cerebral herniation. Contraindications to injecting local anesthetics via the epidural or spinal route include severe hypovolemia and allergy to local anesthetics. It is axiomatic that patient refusal represents an absolute contraindication to an elective procedure. A thorough preoperative assessment of current fetal well-being, maternal volume status, intrapartum systemic opioid use, antibiotic administration for ongoing chorioamnionitis or other infectious process, and a brief reiteration of known maternal disease states, including allergies, will readily identify most of the major concerns that would render neuraxial anesthesia potentially hazardous. The anesthesia provider should weigh the risks and benefits of neuraxial anesthesia for each patient.

Informed consent should include a frank discussion about anesthetic procedures and risks (seeChapter 32). Surveys of postpartum women have demonstrated that most parturients want to know the possible complications of epidural analgesia, even those that are rare.17,18 It is best to relay this information before the onset of labor (e.g., during antenatal classes), or early in the intrapartum period, although doing so is not always feasible.19 Some anesthesia providers fear that distressed, desperate, or sedated parturients may not understand the discussion of anesthetic procedures. A 2017 survey study of 206 postpartum women found no difference in recall of risks (discussed early after admission for labor) between women with and without pain at the time of the consent discussion.20 The preanesthetic evaluation allows the physician to communicate a sense of concern and to demonstrate a commitment to the patient's care. Most laboring women understand the need for informed consent, and they appreciate the opportunity to participate in decisions about their care. Adequacy of consent can be demonstrated not only by documentation of information provided to the patient but also by the lack of patient objection to a procedure and the cooperation provided by the patient during the procedure.

ADEQUATE INFORMATION

The second requirement of informed consent is that the patient must be provided with adequate information with which to make a decision. The right to informed consent is embedded in the nature of fiduciary relationships, wherein one party has differential power, and thus that party has the inherent responsibility to share necessary information with the other. General categories of information that must be provided are the diagnosis; the nature of the proposed procedure; the risks, consequences, and benefits of the procedure; an assessment of the likelihood that the procedure(s) will accomplish the desired outcomes; and any reasonable and feasible alternatives to treatment (including the alternative of not having the procedure) and the risks and benefits of each. In clinical practice, the information required to be disclosed is frequently summarized by using the abbreviation PARQ: P (the recommended medical procedure), A (the reasonable alternatives to the recommended procedure), and R (the risks of the procedure); Q represents the additional step of asking the patient if he or she has any questions about the proposed procedure not adequately disclosed in the discussion.

States are far from uniform in their views of how much information should be disclosed for meaningful informed consent. Various criteria have been proposed as both legal and moral standards for adequate disclosure. The “reasonable physician” standard bases disclosure of information on the prevailing practice within the profession. What would a typical health care provider in the same specialty and “community” disclose about this procedure? This legal standard, the only judicial standard by which courts judged physicians prior to 1972, allows the practitioner to determine what information is appropriate to disclose. It is often argued that this more paternalistic approach, although still dominant in the courts, is inconsistent with the goals of informed consent and true patient autonomy.

The second standard of disclosure, introduced in 1972, is the “reasonable person” standard. The reasonable person standard requires a health care provider to disclose to a patient any material information that the practitioner recognizes that a reasonable person in the patient's position would consider to be significant to his or her decision making about the recommended medical intervention. Risks that are not serious, or are unlikely, are not considered material. Under this standard, the critical requirement shifts from whether the disclosure met the profession's standard to whether the undisclosed information would have been material to a reasonable patient's decision making.

The great advantage of the reasonable person standard is the focus on the preferences of the patient. A requirement for this standard is that the type and amount of information provided must be at the patient's level of understanding if he or she is truly to be an autonomous decision maker. The disadvantages of this standard include its failure to articulate the nature of the “hypothetical” reasonable person. In addition, the retrospective application of this standard presents a significant problem in that any complication of a procedure is likely to seem material after it has occurred (Nora, 1998).

Although the reasonable person standard does focus more on the patient, it does not require that the disclosure be tailored to each patient's specific informational needs or desires. Instead, it bases the requirements on what a hypothetical reasonable person would want to know. The third standard of disclosure, the “subjective” standard, addresses this limitation by asking the question, What would this particular patient need to know and understand in order to make an informed decision? This patient-centered approach allows greater differentiation based on patient preference, relying on the unique nature and abilities of the individual patient to determine the degree of disclosure needed to satisfy the requirements of informed consent. This standard is the most challenging to implement in practice due to its requirement to tailor information specifically to each patient.

In addition to providing information, the clinician has the ethical obligation to make reasonable efforts to ensure comprehension. Communicating highly technical and specialized knowledge to someone who is not conversant in the subject presents a formidable challenge. Patient-centered barriers to informed consent—such as anxiety, language differences, and physical or emotional impairments—can impede the process. Lack of familiarity or sensitivity to the patient's cultural and health care beliefs on the part of the provider can act as a significant barrier to providing effective informed consent. Process-centered barriers, including readability of consent forms, timing of the consent discussion, and amount of time devoted to the process, also may reflect disrespect for the autonomy of the patient.

To optimize information sharing, explanations should be given clearly and simply, and questions should be asked frequently to assess understanding. Whenever possible, a variety of communication techniques should be used, including written forms of educational materials, videotapes, CDs, DVDs, and additional media sources. Computers have taken on a new and ever-expanding role as an effective tool in patient education when integrated into the clinical setting.

Informed Consent: Protecting the Surgeon

Hugh Henderson FRCS

Autonomy and Consent—A False Equivalence?

As we have seen, autonomy is the right to decide one’s own bodily integrity, the moral authority to decide how one’s own physical embodiment may be treated. This chapter has examined how patient autonomy is safeguarded in clinical practice, and found that clinical practice relies heavily on informed consent to ensure that the patient’s autonomy is protected.

To gain a more profound sense of how patient autonomy actually fares in daily medical practice, we may need to push the boundaries a bit. One way to test the boundaries is to ask how diligently the informed consent requirement is enforced in practice. At a fundamental level, we may start by asking how well we provide our patients with a chance to give genuinely informed consent. Intuitively we know that practices will vary considerably in different clinical settings. Informed consent will inevitably be more patient-centered in a fertility clinic than in a radiology department. Nevertheless, it may be informative for readers to consult their experience in familiar settings such as a medium sized medical-surgical hospital.

Many of us have experience with being on rounds when the chief resident tells the intern to “be sure to consent Mrs. X for surgery”. First, “to consent” really should not be a transitive verb, as though consent is something we are doing to poor Mrs. X. We should be facilitating a decision-making process for Mrs. X, helping her to understand her options so that she can make the best possible decision for her own individual needs and objectives.

So “consenting” poor Mrs. X is a bit brutal. Perhaps the intern and chief resident simply need to be reminded of the importance of informed consent in practicing patient-centered medicine. Unfortunately, there are still hurdles to cross. Our overworked intern is now “consenting” the patient for a blood transfusion, “tanking her up” for surgery. Why is the transfusion being recommended? What are the indicia for transfusing blood, given her hemoglobin level and comorbidities? What are the possible complications that might arise from a blood transfusion? Mrs. X wants to know how likely it is that she will get HIV from the transfusion. Hepatitis? Ebola? The intern may not be able to contribute much information to this informed consent.

Now, we will push the boundaries a little further. Does the court system promote patient autonomy when Mrs. X sues her physician for failure to provide adequate information to allow her to give informed consent?1 One may recall that Judge Cardoza’s pronouncement in 1914, in the case of Schloendorff v. Society of New York Hospital,1 emphasized consent per se, using the language of assault and battery. By 1957, Salgo v. Leland Stanford Jr. Univ. Bd. of Trs.5 shifted the focus from whether the procedure was authorized, to asking whether the patient’s consent was adequately informed. Salgo thus places the emphasis on the information that was needed to allow the patient to provide adequately informed consent.

In the wake of the Salgo decision, courts across the country adopted the principle that patient autonomy relies on the adequacy of information provided to the patient. At this point, however, the story takes an unexpected twist. Many courts continued to give significant discretion to physicians to decide the amount of information that was sufficient for patients to make informed decisions. This was referred to as the “professional” or “physician” standard, in which the adequacy of disclosure was that which would be provided by a reasonable medical practitioner.6

Physicians, on the whole, may not always provide much information to patients, yet the physician standard of practice asked what the majority of physicians in the community would do. For jurisdictions that adopted the physician standard, expert medical testimony was required to establish what would be considered customary disclosure in the medical community. With the emphasis being placed on what physicians would do rather than the information that consenting patients would need, the physician standard arguably constituted a step away from patient autonomy.

In 1972, the influential D.C. Federal Circuit announced in the case of Canterbury v. Spence, that “it is the prerogative of the patient, not the physician, to determine for himself the direction in which his interests seem to lie.”7 The patient was the one who should determine the adequacy of the information being provided. Canterbury’s patient-oriented standard asked what a reasonable person in the patient’s position would consider important. As a result, expert testimony was not relevant, since juries were better suited to determining what a reasonable patient would consider important. This new “patient-centered” approach created an alternative standard for judging the adequacy of the information provided to the patient.

In 2007, David Studdert and colleagues8 performed an empirical study examining whether jurisdictions across the United States apply the physician standard (disclosure that a reasonable physician would make; based on expert medical testimony); the patient-centered standard (disclosure a reasonable patient would require; no expert testimony needed); or an alternative standard. Studdert and colleagues found that 25 states had adopted the patient-centered standard: 23 states followed the physician standard, and the remaining 2 states, Georgia and Colorado, used a hybrid standard. Thus, as of 2007, the nation is evenly split between the physician standard and the patient-based standard.

Returning to our question: When lawsuits allege that the treating physician provided inadequate information to allow the patient to give informed consent, do courts protect patient autonomy? We are now in a position to make several interesting conclusions. In the United States, state courts follow essentially two standards:

25 states:

“Patient-centered” standard

Disclosure a reasonable patient would require to permit informed consent

No expert testimony needed

An OBJECTIVE standard

23 states:

“Physician” standard

Disclosure a reasonable physician would make

Requires expert medical testimony

An OBJECTIVE standard

The patient-centered standard seeks the perspective of patients, whereas the physician standard seeks the perspective of doctors. This seemingly brings the patient-centered standard closer to protecting a patients’ autonomy, which is the goal of informed consent. By contrast, the physician standard asks what physicians think is important. In fairness, it must be pointed out that physicians have more experience than the lay public with complications and risks attendant to procedures they perform. Physicians may arguably be better able to address the risks and benefits of a procedure. Nevertheless, juries may arguably be a step closer to a patient’s actual worries.

Another important point is lurking in the background, and has yet to be addressed. In the law, there are two important burdens of proof for determining a defendant’s fault or culpability. They are the objective standard and the subjective standard. The distinction comes up most often when comparing criminal law to civil law. In criminal law, we often hear that the state must prove “intent,” meaning that the defendant intended to do the illegal actions that he or she is accused of. In criminal law, the defendant must have mens rea, or “guilty mind,” to be found guilty of a crime. This is referred to as a subjective standard, meaning that the defendant must actually have intended to perform the illegal acts.

In civil law, on the other hand, negligence cases involve one party claiming that another breached a duty of care, and that breach resulted in an injury. These are not criminal trials, and are instead referred to as “civil” cases. In civil cases, the injured party is not required to prove that the defendant intended to commit harm, which would be a subjective standard. Instead, the question is whether the defendant breached the “standard of care” that ordinarily prudent people would exercise in the same situation. This is an objective standard since the individual’s mind is not at issue. The question is, objectively, would an ordinarily prudent person have behaved more carefully than the defendant did? If so, the defendant was negligent.

Now to the point. When determining the information that a physician must provide in order for the patient to make informed decisions, the court asks the jury to assess the adequacy of disclosure according to either the patient-centered standard or the physician standard. However, both the patient-centered standard and the physician standard of disclosure are objective standards. The patient-centered standard asks for the level of disclosure a reasonable patient would require to ensure informed consent; The physician standard asks for the level of disclosure a reasonable physician would make to ensure informed consent. Neither standard is subjective. Neither standard asks what thoughts were in the patient’s own mind while she was deciding what to allow the doctors do to her body. If the legal standard genuinely seeks to enforce an individual patient’s autonomy, it should seek to know her own concerns, rather than asking a group of jurors or a group of doctors what they would have done. Autonomy is about the very personal decisions a single individual makes regarding her own body. Personal autonomy, by definition, means having the right to have one’s preferences respected, even if they are eccentric. Anything else is just a group decision.

As a practical matter, it would admittedly be difficult for juries to inquire into the mind of the plaintiff at the time of the informed consent discussion. It would also be very difficult to reconstruct the discussion sufficiently well to assess whether the physician was negligent. Nevertheless, juries have been entrusted to be fact finders for centuries. And perhaps, if autonomy is to be respected, we need to think about improving the consent process in a manner that keeps patient autonomy at the forefront. Objective standards such as the patient-centered and physician standard are problematic. Imagine that the opinion of peer physicians is that, in thyroid surgery, the risk of injury to the recurrent laryngeal nerve is so remote that it would be unwise to include it in the informed consent conversation, lest the patient refuse the surgery out of excessive fear. Depending on how small the risk is, this approach may seem medically valid. Eventually, however, a physician will have a patient whose single greatest joy in life is singing in the church choir.

There have been many approaches to improving the informed consent process. Individual hospitals or hospital systems frequently design templates for specific procedures such as blood transfusions. Such templates can help ensure that the disclosures are complete, and they can be designed to include boxes to stimulate questions from the patient that can be noted on the form.

Some states have passed statutes designed to enhance the informed consent process. For example, the State of Louisiana passed the Uniform Consent Law,9 which is designed for the purpose of improving faithful documentation of the informed consent process and clarifying proof issues should the informed consent be the subject of litigation. Under the Uniform Consent Law, if a patient sues a physician on the basis that the physician’s disclosure of the risks was inadequate, the physician can only be liable for failure to disclose risks that could have influenced a reasonable person in deciding to give or withhold consent. In other words, the patient cannot argue that the consent did not address her own specific concerns, but only that a reasonable person would have considered the disclosure important. This is the “patient-based” standard discussed earlier.

The next important feature of Louisiana’s Uniform Consent Law is that the Secretary of Health will prepare a list of procedures that require disclosure of risks, and specify the disclosure that is required for each such procedure. The statute then provides that, if a patient’s consent to a procedure is documented on an approved form that contains the disclosures required by the Secretary of Health, the patient’s consent is presumed. If a physician does not use the approved form, then the burden of proof shifts to the physician to demonstrate that the informed consent process was adequate. In short, if the physician uses the State’s form, consent is presumed to be valid. Otherwise, the burden is on the physician to prove that the patient gave properly informed consent.

Legal Implications

Informed consent is primarily an ethical standard of clinical medicine used to protect the interests of the patient. However, informed consent does have an important legal aspect as well. In the legal context, informed consent is the documentation of the process of communication with the patient about the procedure. The rigor of this legal requirement can vary from institution to institution. In some instances, documentation of the informed consent process does not require completion of a standard informed consent form. Instead, this discussion may be documented in a narrative form in the medical record. It is important to keep in mind that both the legal and ethical requirements of informed consent should be met before a surgical procedure is undertaken. Though the legal requirement of documentation is important, it should not take precedence over the process of communication that is necessary for patients to make well-informed decisions about their health care.

The dual identity of informed consent as both an ethical process of communication and legal documentation of this discussion can be the source of confusion. This dual nature can mislead providers about the purpose of informed consent and what steps are necessary to achieve it. In many instances, physicians believe that documentation requirements take precedence when obtaining informed consent. However, physicians must be aware that the process of communication necessary to facilitate the patient's decision-making is not substituted by the completion of a legal document. It is important to keep in mind that not all legal documents with a patient's signature or description of a discussion reflect that an adequate informed consent process has taken place. In these instances, patients might not have been adequately educated about the procedure or understood the ramifications of the risks before signing a document.

Other misunderstandings occur when the emphasis of informed consent is placed on documentation rather than communication. Specifically, physicians are led to believe that the purpose of informed consent is to protect them when adverse outcomes occur. This notion of informed consent is erroneous for at least two reasons. First, the practice of informed consent was evolved out of a need to protect the patient's interests.5 Informed consent was never intended to be a mechanism to protect physicians. The mid-20th century marked a change in medical practice, moving away from notions of paternalism and toward autonomy. The doctrine of informed consent was established to prioritize patients' autonomous wishes in decisions about their medical care. Second, it is important for physicians to recognize that a signed consent document does not guarantee protection from legal action in the case of an adverse outcome. Legal precedent has clearly demonstrated that physicians can be held accountable for battery and negligence in a court of law even when the patient signed an informed consent document before the surgery.6

Physicians are required to obtain informed consent directly from the patient before beginning a surgical procedure. There are a few exceptions to this standard. Modification of the standards of the informed consent procedure are required when treating incompetent or minor patients or in emergency situations.

Informed Consent

Proper informed consent is necessary before beginning any dental procedure (Figure 16-8). According to Beckett,16 an insurance company vice president:

Informed consent represents the intersection of communication and documentation at critical junctures in patient care . . . . Informed consent is a process, not a piece of paper. In our experience, informed consent is still widely underutilized in dentistry. In many instances where consent forms are used, the consent is just a signature at the bottom of a form full of clinical jargon. It's unfortunate there is so much resistance to informed consent, since it pays dividends far in excess of the time it takes to do it right. Most dentists will have occasion to use informed consent procedures and forms at one time or another, so it's worth a few moments’ consideration about how to get the most benefit out of the informed consent process with your patients. Informed consent offers the dentist an opportunity to enhance rapport with patients, as well as to create reasonable patient expectations about the desired outcome of a procedure or course of treatment. How best to take advantage of this opportunity? Keep in mind that while you know the issues at hand very well, the same is not true for patients. Most patients don't go through the informed consent process very often, so treat each informed consent discussion as though it is the first for your patient. Don't rush your verbal presentation of information, and try to avoid situations where the patient is expected to read (and understand!) a consent form while you are simultaneously speaking to them. Informed consent is not just about getting a form signed: it involves a process of advising the patient and obtaining voluntary, knowledgeable consent for a procedure. When the process is executed properly, there should be clear documentation of a patient's voluntary consent to treatment. This process can be successfully completed without a form, but using a standard form accomplishes several goals. Several parts of the patient record can and should be used during the informed consent process as they summarize the foundation for the patient's knowledgeable, voluntary decision to accept or refuse care, along with commonly known risks and benefits associated with the patient's choice of treatment.”

Some practitioners do not use written informed consent forms for laser treatment, believing that laser treatment is currently the standard of care—and by using a written informed consent form, the dentist is highlighting to the patient that laser treatment is somehow “different” and potentially more dangerous. Other laser dentists insist on written informed consent forms specifically to highlight that laser surgery is “different” and by implication, superior. Some practitioners use standard informed consent forms, whereas other practices use specific laser dentistry informed consent forms. How to approach informed consent is the choice of each practitioner.