Informed consent process

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  • Core Principle: A process, not just a signature. Ensures patient autonomy.
  • Capacity Assessment: Patient must be able to understand, appreciate, reason, and communicate a choice. Assumed present unless proven otherwise.
  • Key Components: 📌 Mnemonic BRAIN
    • Benefits: Expected positive outcomes.
    • Risks: Potential complications, including non-treatment.
    • Alternatives: Other viable options, including no treatment.
    • Indications: The reason for the procedure.
    • Nature: What the procedure entails.

Doctor and patient reviewing medical consent form

  • Exceptions to Consent:
    • Emergencies (life/limb threat)
    • Waiver (patient defers decision)
    • Incompetence (use surrogate/advance directive)

Therapeutic Privilege: A rare exception where disclosing information would cause severe, direct harm to the patient. Must be documented and is ethically controversial.

Core Components - What to Tell

  • Diagnosis & Natural Course: The patient's condition and the expected outcome if left untreated.
  • Nature of the Procedure: A clear, simple explanation of what the surgery involves.
  • Risks & Benefits:
    • Benefits: The potential positive outcomes and likelihood of success.
    • Risks: Detail significant potential complications, including common, minor issues (e.g., bleeding, infection) and severe, rare events (e.g., major organ injury, death).
  • Alternatives:
    • All viable alternative treatments, including medical management or less invasive options.
    • Must include the option of no treatment and its associated risks and benefits.
  • Questions: An opportunity for the patient to ask questions and have them answered.

📌 Mnemonic: BRAIN

  • Benefits
  • Risks
  • Alternatives
  • Indications
  • Nature of procedure

⭐ The most common reason for malpractice litigation is not surgical error, but a failure in communication, especially regarding potential complications and obtaining informed consent.

Doctor explaining surgical options to patient on tablet

Capacity vs. Competence - Who Decides?

  • Capacity: A clinical determination made by a physician. It is task-specific and can fluctuate (e.g., delirium).

    • Assesses if a patient can:
      • Communicate a choice
      • Understand relevant information
      • Appreciate the situation & consequences
      • Reason about treatment options
    • 📌 Mnemonic: CUAR ("cure")
  • Competence: A legal state determined by a judge in court. It is a global, not task-specific, assessment.

⭐ A patient's refusal of a physician-recommended treatment does not automatically imply a lack of decision-making capacity. The key is the process of their reasoning, not the outcome of their decision.

  • Emergencies: Consent is implied for life/limb-saving procedures if a patient is incapacitated and no surrogate is available.
  • Incapacitated Adults: If a patient lacks decision-making capacity, obtain consent from a surrogate.
    • Surrogate Hierarchy:
  • Minors: Consent from parents/guardians, with exceptions:
    • Emancipated or married minors.
    • Specific care: Contraception, STIs, pregnancy, substance abuse.
  • Patient Refusal: A competent adult has an absolute right to refuse treatment, even if life-saving.

⭐ In a true emergency, the principle of implied consent allows proceeding with life-saving treatment without explicit consent. Thorough documentation is key.

High‑Yield Points - ⚡ Biggest Takeaways

  • Informed consent is a process requiring disclosure of risks, benefits, and alternatives (BRAIN).
  • The patient must have decision-making capacity (understand, appreciate, reason, communicate).
  • Exceptions include emergencies, patient waiver, and therapeutic privilege.
  • If a patient lacks capacity, a surrogate decision-maker is required.
  • For minors, obtain assent from the child and consent from the parent/guardian.
  • Consent must be voluntary, free from coercion, and properly documented.

Practice Questions: Informed consent process

Test your understanding with these related questions

A 16-year-old girl comes to the physician for a regular health visit. She feels healthy. She lives with her parents at home. She says that the relationship with her parents has been strained lately because they ""do not approve"" of her new boyfriend. She recently became sexually active with her boyfriend and requests a prescription for an oral contraception. She does not want her parents to know. She smokes half-a-pack of cigarettes per day and does not drink alcohol. She appears well-nourished. Physical examination shows no abnormalities. Urine pregnancy test is negative. Which of the following is the most appropriate next step in management?

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Flashcards: Informed consent process

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EF < _____% and MI within _____ months are absolute contraindications to non-cardiac surgery

TAP TO REVEAL ANSWER

EF < _____% and MI within _____ months are absolute contraindications to non-cardiac surgery

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