Capacity, competence, and consent

Decision-making capacity, legal competence, and informed consent are pillars of patient autonomy and essential components of health care provision. To maintain patient autonomy, the informed decisions of patients with decision-making capacity must be respected whenever possible. Because decision-making capacity can become impaired in many circumstances, clinicians must be able at all times to evaluate whether a patient has decision-making capacity and to what degree it is impaired. For patients who lack decision-making capacity, a surrogate decision-maker may be appointed. In most circumstances, a parent or guardian is required to make decisions for unemancipated minors; exceptions include decisions related to reproductive health, mental health, and substance use disorders. Legal competence is related but not identical to decision-making capacity. It applies to a broader context than medical decision-making and is assessed by a court of law. Clinicians must obtain informed consent from patients before providing medical care whenever possible. This involves assessing decision-making capacity and voluntariness, full disclosure of the details of proposed care (e.g., indications, risk-benefit profile, and alternatives), and ensuring that these are fully understood by the patient. In exceptional cases, care may be provided without informed consent, e.g., implied consent for life-saving care, involuntary commitment, or court-ordered treatment. Ethical dilemmas involving decision-making may require consultation with a medical ethicist and/or institutional lawyer to ensure that decisions adhere to applicable laws and ethical best practices.

See also “Principles of medical law and ethics.”

Overview ^[1]

• Definition: a patient's ability to understand and communicate a health care decision based on their preferences and values
• Key considerations
  • Generally, a patient must be ≥ 18 years of age or a legally emancipated minor to have decision-making capacity.
  • Capacity should be assessed and determined by the treating clinician.
  • A patient may demonstrate capacity to make some health care decisions, but not others.
  • Decision-making capacity is not automatically precluded by intellectual disability (e.g., trisomy 21), mental illness, low health literacy, or neurodegenerative disease (e.g., dementia).
  • Unstable manic or depressive episodes or altered mental status may transiently preclude decision-making capacity.
• Required components: All of the following are required for a patient (or their surrogate) to demonstrate capacity. ^[2]
  • Communication of a choice: the ability to clearly and consistently communicate the decision
  • Demonstration of understanding: the ability to comprehend the information provided, including the different options available
  • Appreciation of relevant facts: the ability to recognize and evaluate the facts relevant to the situation
  • Reasoning in medical decision-making: the ability to describe the thought process behind the decision

Assessing decision-making capacity ^[2][3]

Decision-making capacity for low-risk medical decisions can be assumed if the patient demonstrates understanding during a conversation.

• Indications
  • Informed consent is required (e.g., prior to blood transfusions, invasive procedures).
  • Incapacity is suspected.
• Prior to assessment
  • Address low health literacy and communication barriers (e.g., hearing aids, medical interpreter).
  • Treat reversible causes of incapacity (e.g., intoxication, delirium).
  • Consider the cultural context of the decision and its impact on the patient's values.
• Directed interview: There are four required components.
  • Choice: “What decision have you come to?”
  • Understanding: “In your own words, can you describe the risks and benefits of the available options?”
  • Appreciation
    • “How would you describe your current health situation?”
    • “Do you think you would benefit from some form of medical intervention?”
  • Reasoning: “How did you come to your decision?”
• Further assessment: indicated if capacity remains uncertain after a directed interview
  • Consider using a formal assessment tool. ^[4][5]
  • Repeat the assessment to evaluate for changes in capacity.

Identify and treat reversible causes of incapacity (e.g., delirium, infection, intoxication, medication) before assessing capacity.

Do not mistake pseudoincapacity (i.e., a lack of understanding due to insufficient patient counseling and/or use of jargon) or a decision against medical advice for lack of decision-making capacity. ^[2]

Shared decision-making ^[6]

• Definition: a process in which the patient and clinician work together to make a health care decision
• Indication: nonemergency situations in which there is clinical equipoise
• Goals
  • Patient empowerment by considering their values, cultural beliefs, and preferences when making a medical decision
  • Improved patient satisfaction and buy-in (e.g., medication adherence)

Three-step model for shared decision-making ^[7]

• Choice talk: : an introductory discussion in which the patient is informed that there are choices available and that they can be involved in the decision-making process
  • Invite the patient to participate in the decision-making process.
  • Explain that there are different ways to approach the decision.
  • Assess the patient's current knowledge and understanding.
• Option talk: a discussion about all of the available options
  • Discuss the risks and benefits of the available options, using decision aids if available. ^[8]
  • Ask the patient about their preferences.
  • Conclude by checking the patient's understanding of all of the options.
• Decision talk: : a discussion in which the patient either makes a decision based on their preferences or defers the decision
  • Ask the patient to confirm or defer their decision.
  • Review the decision using the teach-back method.

If a patient defers a decision, revisit the “decision talk” in subsequent conversations.

Surrogate decision-making ^[9]

• Definition: a model in which another person makes treatment decisions for the patient because they lack decision-making capacity and/or legal competence
• General
  • A surrogate may be appointed by the patient (e.g., medical power of attorney), legally appointed (e.g., court-ordered guardian), or next of kin (if no advance directive exists).
  • Advance directives or surrogates are only used if the patient has lost the ability to make their own decisions. ^[10]
  • Advance directives may be revoked by the patient at any time if they retain decision-making competence.
  • Surrogate decisions should be based on what the patient would have wanted.
• Hierarchy of medical decision-making ^[11][12]
  1. A mentally competent patient capable of making their own decisions
  2. Advance health care directive: prespecified legal instructions from the patient used to guide medical decision-making
     • Living will: a legal document in which individuals describe their wishes regarding their health care (e.g., to maintain, withhold, or withdraw life-sustaining care) should they become incapacitated
     • Durable medical power of attorney (health care proxy): a legal document through which an individual designates a surrogate to make specific health care decisions
     • Oral advance directive: an oral statement made by a patient regarding their preferences prior to incapacitation
  3. Next of kin
     • Spouse
     • Adult child
     • Parent
     • Adult sibling
     • A close friend (in approx. 50% of US states)
  4. Ethics committee or legal consult
• Caveats: if the patient's preferences cannot be determined and there is a disagreement regarding the course of action (e.g., the wishes of a designated surrogate who is not a family member conflict with the wishes of family members)
  • The clinician should facilitate a meeting between the disagreeing parties with the aim of reaching an agreement about what the patient would have desired.
  • No matter what the outcome of the conflict, the wishes of the designated surrogate should be followed.

Oral advance directives may pose problems of interpretation, as oral statements are not as specific or easy to confirm as written statements. The validity of an oral advance directive increases if the patient has made an informed choice, the instructions were specific, and the directive was confirmed by multiple people.

Patients with decision-making capacity and competence have the right to provide or withdraw informed consent at any time (even during a procedure).

The Spouse ChiPS in: Spouse, Children, Parents, Siblings, other relatives/close friends (priority of surrogate decision-making)

Special situations ^[13]

• Harm to others: A decision to decline treatment may be disregarded if that decision endangers others.
• Pregnant individuals
  • A person has the right to refuse certain treatments even if their decision poses a risk to the unborn fetus (e.g., declining a cesarean section). ^[14]
  • For patients with severe mental health disorders, a psychiatric professional should be integrated into the care team to ensure the core ethical principles are upheld. ^[15]
• Changes in capacity: If a patient with capacity makes a decision, it cannot be reversed if the patient becomes incapacitated unless a designated surrogate weighs in to reverse the decision.

Medical decision-making in pediatrics

• Pediatric definitions ^[16]
  • Minor: any person < 18 years of age (in most states)
  • Emancipated minor: a minor who fulfills at least one of the following criteria
    • Lives separately from parents and is financially self-reliant
    • Is married
    • Is on duty in the armed forces
  • Mature minor
    • An unemancipated minor who is deemed to have capacity
    • The status of a mature minor is decided by individual state courts.
    • The exact definition of a mature minor varies state-by-state.
• General ^[17]
  • Unemancipated minors do not possess decision-making capacity.
    • The consent for medical procedures or treatments of unemancipated minors is given by the patient's surrogates (i.e., parents or caretakers).
    • See “Informed consent” below for exceptions and more information.
  • Emancipated minors are considered to be capable of medical decision-making.
  • Mature minor doctrine: a common-law rule that allows mature minors to consent to treatment under certain conditions ^[18]
    • The minor is an older adolescent (the age varies by state law).
    • The minor is capable of understanding the information regarding the medical procedure.
    • The benefits of the procedure clearly outweigh the risks, and the risks are not high.

• Definition: the legal assessment of a patient's ability to freely make conscious decisions (including those regarding their care) ^[19][20]
• General
  • Assessed by a court of law (with input from the patient's family and clinicians as needed)
  • Clinicians do not have the authority to pronounce individuals legally incompetent. ^[1]
  • If an individual is determined legally incompetent, the court will assign a guardian to make decisions on their behalf. ; ^[21]
    • The court may waive the appointment of a guardian or grant a limited guardianship if there is a durable power of attorney.
    • Generally, a guardian cannot issue the commitment of their ward to a mental health facility.
    • The directives of a guardian override the directives of family members.
  • Questions of legal competence arise in the presence of reduced mental capacity (e.g., severe mental illness, intoxication, impulsive/constantly changing decisions, decisions that are inconsistent with the patient's values)

Legal competence assesses an individual's global decision-making ability (e.g., relating to financial, property, and health care decisions), whereas decision-making capacity is a functional assessment that can vary depending on the situation. For example, a patient may have the capacity to choose between blood pressure medications but not to consent to complex surgery. ^[3]

Overview ^[22]

• Definition: the process of attaining the patient's authorization for a medical test, treatment, or procedure
• Key considerations
  • Ensure that there is sufficient time before the intervention for the patient to make a well-considered decision.
  • A patient with decision-making capacity is free to provide or revoke their consent at any time; it does not need to be in writing.
• Required components: applies to the patient or their surrogate ^[23]
  • Voluntariness: The decision must be made without coercion.
  • Capacity: Decision-making capacity must be demonstrated before consenting to the intervention.
  • Comprehension: The decision-maker must demonstrate understanding of the ramifications of the proposed intervention.
  • Disclosure: Relevant medical information regarding the intervention must be disclosed.

Obtaining informed consent ^[13]

Informed consent should be obtained by the health care provider performing the intervention.

1. Inform the patient of the benefits, risks, alternatives, and indications of the intervention and the nature of their illness, including:
   • Known complications and estimated risk of death and morbidity
   • Alternative interventions
   • The expected nature of the disease course without any intervention
   • If any aspect of the proposed intervention is experimental
2. Notify the patient about the identity and level of training of each potential participant in the intervention, allowing them to either give or withhold informed consent.
3. Assess the patient's decision-making capacity ; (e.g., using the teach-back method) and ability to consent voluntarily.
4. Document the decision that the patient (or their surrogate) has clearly articulated.

Use your BRAIN when obtaining informed consent: Benefits, Risks, Alternatives, Indications, Nature

Performing an intervention without having obtained informed consent may legally constitute battery and/or negligence. ^[24]

The amount of information shared when obtaining informed consent depends on the frequency and severity of the risks involved, e.g., less information needs to be disclosed for venipuncture than for cardiac catheterization. ^[13]

Exceptions to standard informed consent ^[25]

• Life-threatening emergencies (e.g., an unconscious trauma patient without a surrogate present)
• The patient lacks decision-making capacity, but their surrogate has authorized intervention.
• The patient decided to waive the legal right of informed consent.
• Disclosing may pose a threat to the patient or affect their decision-making capacity (i.e., therapeutic privilege).

Difficulties in obtaining consent should not delay life-saving procedures.

Language and use of an interpreter ^[25][26]

• Discuss health care decisions with patients in terms they can relate to.
• Communicate in a language that the patient understands.
• Request an interpreter if you are unable to communicate with the patient in a language in which you can have a comprehensive discussion and assess the patient's understanding of the relevant information.
  • Both in-person and remote (e.g., phone, video) interpreter services are appropriate.
  • Communicating without an interpreter can result in patients unknowingly consenting to unwanted procedures, misunderstanding their diagnosis, and/or complying poorly with medical advice.
• For more information about particular instances of the use of medical interpretation, see “General concepts of patient counseling” in the “Patient communication and counseling” article.

Multilingual relatives are not acceptable alternatives to professional interpreters in the nonemergency medical setting.

Parental consent for minors ^[27]

• Overview
  • Minors are considered legally incompetent to make medical decisions.
  • Parental consent is generally required before a minor receives medical care; exceptions are listed below.
  • Although not legally mandatory, it is recommendable that clinicians obtain the minor's approval for medical care.
  • For children to participate in medical research, documented consent must be obtained from parents or guardians and assent must be obtained from minors. ^[28]
  • If the parents of the patient are themselves minors, grandparents may give consent for their grandchildren.
  • For minors who have been removed from their parental care and whose parent's right to consent has been revoked by a juvenile court, the court must assign a guardian (e.g., grandparent) who can provide consent.
  • In the absence of another guardian, child protective services authorize all health care services for children whose parents have had their parental rights terminated.
• Exceptions to the requirement of parental consent
  • Emergency and/or life-saving interventions (e.g., severe trauma, suicidal ideation, blood transfusion for life-threatening hemorrhage). ^[29]
  • The minor is legally emancipated.
  • Care regarding sex (e.g., contraception, STIs, pregnancy care except for abortion in most states) ^[30][31]
  • Addiction care (e.g., health services to treat drug and/or alcohol dependency) ^[30][32]
  • Minors who are parents themselves or who are married
  • Minors should be encouraged to discuss medical issues with their parents regardless of the exceptions that apply.
• Refusal to consent ^[33]
  • Generally, parents and legal guardians may refuse any treatment for a minor under their care in non-life-threatening situations.
    • A parent cannot refuse an emergencylife-saving intervention for a minor for any reason (e.g., religious refusal). ^[29]
    • This refusal is only acceptable if that decision does not pose a risk of serious harm to the minor. Legal intervention (e.g., court order) may be necessary to mandate treatment for a non-emergency but fatal medical condition against the parent's or legal guardian's refusal to consent. ^[34]
    • Clinicians should always attempt to address concerns motivating the refusal of treatment (e.g., misunderstanding of the procedure, fear of potential side effects).
    • Clinicians should respect religious beliefs and/or cultural values of patients that may affect treatment and make therapeutic decisions accordingly within the legal scope of what treatment may be refused.
  • Parents are legally permitted to refuse vaccinations for their children. ^[35]
    • In rare cases, it may be appropriate to overrule a parental decision to decline immunization (e.g., in emergencies such as a child with a contaminated puncture wound and signs of life-threatening tetanus infection). ^[36]
    • Efforts should be made to understand the parents' refusal to vaccinate their children and, where possible, to help them understand the advantages of vaccination.

Unexpected findings during surgery ^[37]

• The patient should be informed about the possibility of intraoperative findings that may require more intervention than originally planned.
• If consent was not obtained
  • If a finding requires immediate action (e.g., appendicitis is found during surgery for ectopic pregnancy), the procedure can be performed without obtaining the patient's consent.
  • If a finding does not require immediate action (e.g., findings concerning for pulmonary malignancy during surgery for tension pneumothorax), the patient should give informed consent before any other procedures are performed.

• One-Minute Telegram 94-2024-1/3: The effect of caregiver race on shared decision-making in critical illness

Interested in the newest medical research, distilled down to just one minute? Sign up for the One-Minute Telegram in “Tips and links” below.