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Public Health Sciences

Informed Consent

~6 min read4 sections
โญ High-yield๐ŸŽฏ Drill Public Health Sciences
Contents (4)

Informed consent is a process, not a signature. It is the practical expression of respect for autonomy, and questions test whether all of its elements are present and whether a recognised exception applies.

  • Required elements: the patient has decision-making capacity; the physician discloses the diagnosis, the nature and purpose of the proposed intervention, its risks and benefits, the reasonable alternatives including doing nothing, and the likely consequences of refusal; the patient understands; the decision is voluntary, free of coercion; and the patient authorises the intervention.
  • Consent must be obtained by someone able to explain the procedure โ€” typically the physician performing it, not a nurse or clerk handing over a form.
  • Recognised exceptions:
  • Emergency: implied consent when treatment is immediately necessary and the patient cannot consent.
  • Lack of capacity: proceed through the surrogate decision-making hierarchy.
  • Waiver: the patient explicitly declines to be informed.
  • Therapeutic privilege: withholding information believed to cause serious harm โ€” narrowly construed and rarely the correct exam answer.
  • A signed form without understanding is not consent, and a patient may withdraw consent at any time, including after a procedure has begun.

(Seed article โ€” remaining sections to be written and reviewed.)

Capacity vs. competence

  • Capacity: a clinical, decision-specific judgment made by any physician at the bedside. The widely used Appelbaum and Grisso framework requires four abilities: communicate a choice, understand the relevant information, appreciate how it applies to one's own situation, and reason by comparing options. Capacity is task-specific and can fluctuate โ€” a delirious patient may regain it by morning.
  • Competence: a legal status determined only by a court, global and durable until reversed. Exam stems that say "the court declared him incompetent" are signaling a guardian, not a bedside assessment.
  • A capacitated patient may make a choice others consider unwise. Refusing a life-saving transfusion is not itself evidence of incapacity; the reasoning process, not the outcome, is what is assessed.

Standards of disclosure

  • Reasonable patient (materiality) standard: disclose what a reasonable patient in this situation would want to know. This is the majority U.S. rule (Canterbury v. Spence) and the default assumption on exams.
  • Reasonable physician (professional) standard: what a similar practitioner would disclose (Natanson v. Kline) โ€” the older minority rule.
  • Subjective standard: what this particular patient would want to know; hardest to litigate, rarely tested.

Voluntariness: the decision must be free of coercion, manipulation, and undue inducement. Pressure from family, an employer, an incarcerating institution, or an enrolling investigator undermines consent even when disclosure was complete.

Consent for research is distinct: the Common Rule (45 CFR 46) requires IRB review, an explicit statement that the activity is research, and disclosure that participation is voluntary and refusal carries no penalty. Therapeutic misconception โ€” the patient believing a trial is individualized care โ€” is a consent failure.

Surrogate decision-making standards, in order: the patient's expressed wishes (advance directive, POLST), then substituted judgment (what this patient would have chosen), then best interests (only when preferences are unknowable). The AMA Code of Medical Ethics frames consent as an ongoing communication process, not a document.

Worked stem โ€” the unconscious trauma patient: A 24-year-old is brought in after a motorcycle crash, hypotensive with a distended abdomen and a GCS of 6. No family is present. FAST is positive. The best next step is to proceed to laparotomy under implied (emergency) consent โ€” treatment is immediately necessary, the patient cannot consent, and no surrogate is available. Delaying to locate a relative is the classic wrong answer. EMTALA independently obligates stabilization regardless of consent logistics.

Change one variable at a time

  • Patient is awake, alert, oriented, and refuses surgery. Assess capacity, not compliance. If he understands, appreciates, and can reason, his refusal governs โ€” document it, offer alternatives, and keep the door open. Court order and "treat anyway" are distractors.
  • Patient is intoxicated and combative. Intoxication may impair capacity. Treat under emergency implied consent for the immediately life-threatening injury; reassess when metabolically clear.
  • Wife present, no advance directive. Follow the state surrogate hierarchy โ€” typically healthcare agent, court-appointed guardian, spouse, adult children, parents, siblings โ€” and instruct her to apply substituted judgment, not what she personally wants.
  • Card in wallet: "No blood transfusions โ€” Jehovah's Witness." An unambiguous written directive from a previously capacitated adult binds. Give crystalloid, cell salvage, and hemostasis; withhold blood.
  • Patient is 16 and unaccompanied. Emergency care proceeds; do not delay for parental consent. The AAP notes that outside emergencies, minors may independently consent for STI, contraception, pregnancy, substance use, and mental health services in most states, and that emancipated minors (married, military, financially independent, or court-declared) consent as adults. For everything else, obtain parental permission plus the child's assent.
  • The surgeon is scrubbing and asks the intern to "get the consent." The person able to explain the procedure and its alternatives must obtain it โ€” decline and hand it back to the operator.

  • A signed form is documentation, not consent. If the stem says the patient signed but cannot describe what will be done, consent is invalid โ€” re-educate before proceeding. The Joint Commission treats consent as a documented process.
  • Capacity is clinical and decision-specific; competence is a court's word. A patient can have capacity to refuse an IV and lack it for a complex operative decision. Refusing recommended care is never by itself proof of incapacity.
  • Emergency = implied consent, and only for the immediately necessary intervention. Do not extend it to elective add-ons discovered intraoperatively unless delay would harm the patient.
  • Therapeutic privilege is almost always the wrong answer. Withholding a cancer diagnosis because family requests it is not sanctioned; the AMA Code directs the physician to ask the patient how much they want to know โ€” which converts it into a waiver, the legitimate route.
  • Consent is revocable at any moment, including mid-procedure if the patient is awake (e.g., during an awake bronchoscopy or a colonoscopy under light sedation). Stop if it is safe to stop.
  • The single most tested association: reasonable patient (materiality) standard โ€” disclose what a reasonable person in the patient's position would want to know, from Canterbury v. Spence. Schloendorff supplies the buzzword "every human being of adult years and sound mind has a right to determine what shall be done with his own body."
  • Minors: emergency care never waits for a parent; emancipated minors consent independently; and STI, contraception, pregnancy, substance use, and mental health care are common minor-consent exceptions per AAP guidance and state law. Pediatric practice pairs parental permission with child assent.
  • Common distractor: calling the ethics committee, obtaining a court order, or asking a psychiatrist to "declare incompetence" when the treating physician can and should simply assess capacity at the bedside.

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