INTRODUCTION — Physicians have a legal and ethical responsibility to provide adequate information to the patient so that they are able to process the information and make appropriate decisions . An educated patient also benefits the physician, both in terms of cooperation in the planned intervention and in reducing acrimony in case of complications . The physician who teaches and responds carefully brings the patient into the medical decision-making process, addresses the patient's concerns, and creates reasonable expectations regarding outcomes. As it is a common procedure, issues surrounding cholecystectomy are used to provide examples of how to apply the concepts in this topic.
This topic focuses on the informed consent session. Additional information regarding the consent process and related ethical issues for adolescent health care, gynecologic care, the intensive care unit, and end-of-life care is presented elsewhere. (See "Consent in adolescent health care" and "Overview of preoperative evaluation and preparation for gynecologic surgery", section on 'Informed consent and patient expectations' and "Ethics in the intensive care unit: Informed consent" and "Legal aspects in palliative and end-of-life care in the United States".)
BENEFITS OF INFORMED CONSENT — The benefits of obtaining informed consent extend beyond the simple transmission of information from someone who has knowledge (the physician) to someone who does not (the patient). The benefits of truly informed consent include :
●Protecting the patient's right of self-determination
●Engaging the patient in their health care
●Enhancing the physician-patient relationship
●Encouraging physicians to thoroughly review the patient's therapeutic options
●Reducing discontent and litigation when there are complications
INFORMED DECISION-MAKING — No intervention can be undertaken without the patient's consent, which must be both voluntary and knowing . In order for consent to be valid, the patient must be competent. In the setting of informed consent, competence or capacity means the patient has the mental ability to understand problems and make decisions about accepting or rejecting medical treatments that are offered .
●Competence is always presumed unless there are obvious clinical (eg, severe mental illness) or judicial (eg, a determination of incompetence at a competency hearing) reasons to doubt competency. If a patient is deemed incompetent by a court of law, the duty of informed consent extends to the patient's proxy.
●In instances of temporarily diminished capacity, a physician is obligated to reassess capacity to consent over time .
In order to meet the requirements for effective, informed decision making, a physician must disclose material facts as well as appropriate additional disclosures. These are discussed in detail below.
Material facts — Material facts are those that are relevant to decision making and usually include :
●Diagnosis. The methods and alternative means of diagnosis may be relevant, particularly when invasive diagnostic techniques are utilized .
●Proposed treatment or procedure.
●Alternative treatment options (surgical or medical) along with their risks and benefits.
●Risks and benefits of treatment.
●The risks of refusing treatment.
Material facts in general include information about events that occur frequently, even if these complications would be considered minor, such as a superficial wound infection or a hematoma. Material facts also include rare events that represent major complications (eg, death, loss of mobility, loss of reproductive function or continence, or the need for a stoma) . As an example, in the case of an elective cholecystectomy, the discussion should include the diagnosis (eg, symptomatic stones), proposed treatment (eg, laparoscopic cholecystectomy), alternatives (eg, observation on a low fat diet), risks of cholecystectomy (eg, common duct injury, infection, bleeding, all of which might require second procedures), and the risks of observation only (eg, stone migration or cholecystitis).
The physician must decide what facts about a procedure should be presented and how detailed the discussion with a patient should be. There are no hard and fast rules about percentages of risk or degrees of harm that require discussion. However, the applicable standards may vary from one patient or jurisdiction to another. As an example, in Texas, state regulations delineate specific risks or hazards associated with certain procedures that must be disclosed in each instance [6,7]. (See 'The duty to inform' below.)
While the law remains unsettled, it seems prudent to include a warning that coronavirus disease 2019 (COVID-19) positive patients undergoing surgical procedures incur higher risks for respiratory complications and mortality . Thus informed, patients who are planning elective surgeries may decide to postpone them.
Physician disclosure — Physicians must answer truthfully if a patient asks questions about the number of similar procedures they have performed and their success rates [9,10]. Failure to answer honestly may leave a physician open to claims of fraud and misrepresentation, as well as negligent nondisclosure [11,12]. A surgeon should disclose the availability of specialty services provided elsewhere if there is a known difference in the quality or types of care delivered there. There is typically no affirmative duty to investigate other surgeons' caseloads or success rates, something one might have difficulty uncovering.
The law mandates disclosure of a physician's financial conflict(s) of interest, since the law presumes that there is the potential for undue influence on that physician's medical judgment . Examples include referral to a laboratory, an ambulatory surgery center, or a radiology service in which the physician has ownership. Patients must be given the opportunity to seek care in an independent facility. There may also be disclosure requirements if the physician has a commercial interest in the use of a patient's cells or in the use of new devices or techniques .
Patients are not entitled to know everything about a provider's personal attributes, even though patients might argue that the information would surely have affected their choice of surgeon . Some courts have mandated disclosure of a physician's own alcohol abuse  and HIV status [17,18]. Other courts refuse to mandate voluntary disclosure, concluding that those physician-specific facts are not material, and that it is an unwarranted invasion of the physician's privacy .
Personnel — The surgeon must advise patients of personnel and their respective roles, including residents, students, and equipment representatives. It is particularly important for patients to know if residents or students will be performing segments of a procedure . It is generally not necessary to name residents or students individually on the consent form, as a generic reference to "residents" and "students" will typically suffice . Some patients object to having part or all of their procedure done by others than the physician they originally chose, and patients retain the right to refuse participation by residents and students. Physicians also have the right to refuse to take care of patients who will not allow residents to participate in elective procedures.
Additional procedures — It is prudent for the physician to inform patients of any additional procedures that may be predictably necessary for a successful outcome or that are recommended to prevent future health problems. Examples might include en bloc resection of adjacent structures in a cancer operation or creation of a stoma at the time of a left colectomy. If one finds something unexpected, like gallstones discovered at the time of a colectomy, it might be most effective to add a cholecystectomy while the patient is anesthetized and the surgeon is working in the abdomen. However, it might be wiser to ask the family in attendance to consent for the patient on the table, rather than simply proceeding with an incidental cholecystectomy.
EFFECTIVE COMMUNICATION — The physician can maximize the effectiveness of an informed consent session by communicating in terms patients and their families or other caretakers can understand. Important elements of effective communication are discussed in the following sections.
Focus on the patient — The legal principles of informed consent promote patient autonomy, the notion that patients should decide who touches them and how that contact is made. Thus, the physician should be wary of too much pressure, too little information, or too little attention to the patient's need for information, understanding, and comfort . As Supreme Court Justice Benjamin Cardozo once wrote, "Every human being of adult years and sound mind has a right to determine what shall be done with their body" .
Physicians must focus on the patient's understanding and consent. One concrete example of respect for autonomy and avoidance of paternalism is the pacing and content of the informed consent conversation between the surgeon and a patient considered to be "frail elderly." The discussion must be held to allow for comprehension and then communication of the patient's wishes back to the surgeon . Including relatives in the discussion may be good practice when patients allow them to join the conversation, but decisions made by family members can never countermand those of a competent adult patient . (See "A patient-centered view of the clinician-patient relationship".)
Comprehensible language — The language used to obtain consent must be comprehensible to the patient and cannot be a simple list. In order to protect themselves from uncertainty, some physicians give patients exhaustive lists of every conceivable thing that might go wrong. However, the transmission of important information requires more than an impersonal, boiler-plate listing of minutiae . Rather, there should be personal transmission of truly relevant data. The physician should present the information that someone in the patient's situation needs to know in order to make a truly educated decision ("If I were in this patient's shoes, what would I want to know?"). (See 'Material facts' above.)
Educational material — Literature or other teaching tools that are targeted to lay readers, such as patient pamphlets or videos, can improve communication and patient understanding of planned procedures [24-26]. A systematic review that included 115 studies involving more than 33,000 patients found that patients provided with educational material have a more accurate perception of procedural risks, a reduced level of decisional conflict, and a more active role in decision making .
Interpreters — Interpreters are necessary for non-English speakers, and a translator skilled in medical terminology (whether present in person or via videoconference) is ideal for the purpose of transmitting accurate information. Translation should not be left to family members, as they may withhold information from a patient in order to protect him or her from hearing bad news. In such cases, incomplete or misleading information may be all the patient receives, and the physician will not realize that information was not effectively or completely communicated [27,28].
The Joint Commission defines health literacy as "the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions" . The educational, social, and cultural factors that influence the expectations and preferences of the individual must also be considered . Thus, if additional clarification and explanation is needed, the conversation must be expanded, and it must be tailored to the individual needs of the patient. In the end, the patient has to hear, understand, and agree to the proposed procedure. (See "The patient’s culture and effective communication".)
Emergency situations — In emergency situations or when the patient is sick or in pain, the patient may be less capable of receiving, interpreting, or communicating information . When possible, the medical facts of the case should be explained to the patient, and the family if the patient allows.
In some cases, the need for consent may be outweighed by the need for urgent intervention and the physician must proceed as expeditiously as the medical situation requires . If the patient cannot participate cogently, family members should be contacted if they are not present and if time allows. When available, living wills and durable powers of attorney should be consulted to determine who the surrogate decision makers might be.
The duty of informed consent extends to a patient's proxy or surrogate decision maker. If a patient regains capacity, the duty of informed consent returns to the patient and the role of the proxy in informed decision making is extinguished. This is why reassessment of the patient's capacity is essential. (See "Ethics in the intensive care unit: Informed consent".)
Comatose or incompetent patients — Incompetent patients are patients who lack adequate decision-making capacity . Physicians must assess all such patients for capacity regardless of their current (or presumed) incompetence. It may be necessary to seek psychiatric consultation if there is doubt about the patient's capacity. (See "Ethics in the intensive care unit: Informed consent".)
The following guidelines regarding competency should be followed:
●So long as the patient remains competent, their expressed wishes supersede any document or the wishes of any surrogate.
●When patients are comatose or otherwise incompetent, living wills may dictate some elements of care, and durable powers of attorney will name surrogate decision makers who can direct care.
●A transiently incapacitated patient may regain capacity, especially when emerging from the influence of alcohol, drugs, or hospital-administered analgesics or sedatives. Such patients should not be deemed incompetent by default and must be assessed, and reassessed as necessary, for capacity before health care decisions are made, particularly those that are not emergent.
●A patient's status as involuntarily committed for mental illness does not eliminate the need for informed consent, nor does it necessarily prevent that patient from being able to consent to, or to refuse, surgical intervention or other invasive procedures .
●For questions, like competence, which seem to have legal overtones, and for which there seem to be no clear answers, a call to the hospital/corporate attorney before taking action would be wise.
WITHDRAWAL OF CONSENT — Patients may withdraw consent at any time during a procedure, and the physician must then engage in a new informed consent (or informed refusal) discussion .
DOCUMENTATION — Patients may not accurately remember all the facts disclosed in a discussion [36,37]. Thus, a physician must document the content of informed consent sessions:
●The informed consent discussion and its documentation should be done by the surgeon who will be performing the procedure [38,39]. Delegating the responsibility to obtain consent to someone else does not absolve the physician of liability if that consent session is incomplete or ineffective. In some jurisdictions the duty to have that informed consent discussion simply cannot be delegated to anyone other than the surgeon himself/herself [40,41].
●The physician should date and time the written summary of what was said and to whom, making note of relatives, friends, or support staff such as nurses or interpreters who are present. All elements of the discussion should be reduced to writing: diagnosis, proposed treatment with its risks and benefits, and alternative treatments with their risks and benefits.
●It is not sufficient to state that "the risks and benefits were discussed" without further description of the specifics. The physician should document that the patient understood the concepts as discussed and agreed to proceed. In addition, the physician should document that the patient was provided with appropriate literature, that the patient had the opportunity to ask questions, and that those questions were answered. The standard procedure consent document means little, particularly in its generic form. The real work of obtaining informed consent is documented in office or hospital notes. There is generally no need for a witness to the one-on-one discussion in the office or at the bedside.
●The consent form itself is often generated by the facility in which the proposed procedure is to take place, and the signing of that form is generally witnessed by a member of the staff at the facility.
●Documentation is particularly important when patients refuse intervention. The physician must note in the record the specific risks associated with delay or refusal that were disclosed.
●When informed consent cannot be obtained due to an emergency situation or diminished capacity due to intoxication, trauma, or disease, physicians must document in the written record what facts were considered in determining the patient's ability to process information and make reasonable decisions.
●When capacity must be reassessed, further documentation is warranted.
FAILURE TO OBTAIN CONSENT — Failure to provide the necessary, relevant information in a manner that truly communicates with the patient may constitute ineffective, and therefore nonexistent, consent. There are two legal theories of recovery for failure to obtain informed consent: battery action and negligent nondisclosure.
Battery action — A battery action is an action for a "touching" to which the patient did not agree [19,42]. In some jurisdictions, inadequate disclosure of risks adds up to no consent at all, and thus a claim of battery may be made, even if the procedure is technically successful . The rationale in such cases is that a poorly informed patient cannot legally consent in any meaningful way, and thus any nominal agreement is void .
Battery actions are infrequent in the medical arena, and, in most jurisdictions, the typical case in which a plaintiff asserts an absence of informed consent is termed "negligent nondisclosure" . Usually, the patient says they did sign the consent form, but were not thoroughly and comprehensibly made aware of the nature of the proposed procedure and its risks. This claim is sometimes made by itself but is more commonly appended to the standard medical malpractice claim that the physician did not perform the procedure according to industry standards.
Negligent nondisclosure — Negligent nondisclosure cases are typical negligence cases, and as such, there are four elements that must be shown  (see "Malpractice risk associated with surgical procedures", section on 'Physician-patient relationship'):
●Duty – The duty is the requirement that a physician act as a minimally competent, similarly trained, reasonable physician in similar circumstances would act when disclosing information.
●Breach of duty – Breach of duty is failure to meet the minimal standard of care.
●Injury – The injury is the harm that befalls the patient.
●A causal relationship – A causal relationship between the breach and the harm is shown when the patient reasonably declares that they would have refused to undergo the procedure had they known the true nature of the risks.
If all four elements are proven to the jury, the physician is liable for the tort of negligent nondisclosure. Typically, the proof of all four elements lies in the testimony of the plaintiff's expert witness, who must present the following information :
●Define the duty – The details that constitute an appropriate informed consent discussion are defined.
●Identify the breach – The details that were wrongly omitted are defined.
●Clarify the harm – The injuries that were suffered are defined.
●Identify alternatives – The alternatives that a reasonable patient might have selected instead are defined. These may include a different procedure, a different physician, or a different facility. The plaintiff then adds that they, being a reasonable patient, would have refused to consent to the procedure originally offered .
THE DUTY TO INFORM — There are three general ways in which jurisdictions may judge the physician's performance of their duty to inform: the professional standard, the objective patient standard, and the subjective standard. However, each state handles negligent nondisclosure cases differently.
Professional standard — The professional standard of care requires that a physician must disclose those facts that a reasonable physician who was faced with this particular set of circumstances would disclose . Thus, the standard is set by the profession, and the individual physician must adhere to accepted medical standards, as defined by the defendant's expert witness.
Patient-centered standards — Unlike the requirement for expert witnesses in jurisdictions in which the professional standard is applied, there is generally no need for an expert in the patient-centered jurisdictions. An expert may be helpful in presenting the scientific facts about procedures and risks. However, a lay jury is deemed capable of deciding what an ordinary patient would consider relevant in order to consent to a surgical procedure. There are both objective and subjective patient-centered standards:
●Objective – The objective standard of care requires that the physician determine what a reasonable patient would find indispensable when evaluating their options and then include these issues in the informed consent dialogue . For elective, cosmetic, or high-risk procedures, the physician's burden of disclosure is even higher because a reasonable patient might be more likely to decline the proposed procedure or to choose another therapeutic option. The patient must show that, had they known the necessary and pertinent facts, they would have refused to proceed. Thus, the physician must disclose those facts that a reasonable patient in a similar situation would need to know in order to make an informed choice .
●Subjective – The subjective standard for disclosure requires the physician to relay facts that a particular patient deems important in the decision-making process . Proponents assert that the right to self-determination requires that a patient be able to decline a particular treatment even if a reasonable person would consent, and only a subjective standard can fully protect that right . The subjective standard promotes the greatest patient autonomy as compared with the professional standard or objective standard. However, it is difficult for physicians to know what facts are relevant to an individual patient's decision making and defend against hindsight. As an example, a patient may state that they would not have consented to a procedure with the possibility of a particular poor outcome that was not disclosed during the informed consent dialogue. The patient need only declare their own particular belief that they would have refused, and the jury must then simply decide whether or not the patient's claim is credible . This standard is seldom used.
SUMMARY AND RECOMMENDATIONS
●The physician has a legal and ethical responsibility to provide adequate information to the patient so that they are able to process the information and make appropriate decisions. (See 'Introduction' above.)
●No procedure can be undertaken without the patient's agreement. The patient's consent must be voluntary and competent. (See 'Informed decision-making' above.)
●In order to meet the requirements for effective, informed decision making, a physician must disclose material facts relevant to decision making, including the patient's diagnosis, proposed treatment, risks and benefits of the treatment, alternative treatments along with their risks and benefits, and the risks of refusal. (See 'Material facts' above.)
●A physician must answer truthfully, if asked, about the number of similar procedures or cases performed, and disclose success rates. They must disclose, even without inquiry, any financial conflict(s) of interest. (See 'Physician disclosure' above.)
●The physician must advise patients of all personnel involved in their care and their respective roles, including residents, students, and equipment representatives. (See 'Personnel' above.)
●It is prudent for the physician to inform patients of any reasonably foreseeable additional procedures that may be necessary for a successful outcome. (See 'Additional procedures' above.)
●The physician can maximize the effectiveness of an informed consent session by communicating in terms patients and their families or other caretakers can understand. Important elements of effective communication include focusing on the patient, using comprehensible language, offering educational material, and using interpreters when necessary. (See 'Effective communication' above.)
●Patients may not accurately remember all of the facts disclosed in teaching sessions. Thus, the physician must document the content of informed consent sessions. (See 'Documentation' above.)
●Failure to provide the necessary, relevant information in a way that truly communicates with the patient may constitute ineffective, and therefore nonexistent, consent. (See 'Failure to obtain consent' above.)
1 : Berg JW, Appelbaum PS, Lidz CW, et al. Informed Consent: Legal Theory and Clinical Practice, 2nd edition, Oxford University Press, New York 2001.
25 : Informed consent in trauma: does written information improve patient recall of risks? A prospective randomised study.
26 : Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures.
27 : Do professional interpreters improve clinical care for patients with limited English proficiency? A systematic review of the literature.
28 : The impact of language barriers on documentation of informed consent at a hospital with on-site interpreter services.
29 : The impact of language barriers on documentation of informed consent at a hospital with on-site interpreter services.
30 : The impact of language barriers on documentation of informed consent at a hospital with on-site interpreter services.
31 : Room for Improvement: A Systematic Review and Meta-analysis on the Informed Consent Process for Emergency Surgery.
32 : Room for Improvement: A Systematic Review and Meta-analysis on the Informed Consent Process for Emergency Surgery.
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