Principles of medical law and ethics

Liability and litigation

Discharged against medical advice

• Assess Decision-Making Capacity (DMC) First:
  • Must demonstrate understanding, appreciation of risks/benefits, logical reasoning, and consistent choice.
  • Impaired DMC (e.g., acute intoxication, delirium, active psychosis, suicidality) = Pt cannot leave AMA; manage with implied consent or psychiatric holds.
• Explore and Address Underlying Causes: c
  • Prior to processing AMA, identify remediable triggers (e.g., uncontrolled pain, nicotine cravings, opioid/EtOH withdrawal, family/pet obligations).
  • Treat promptly (e.g., offer nicotine replacement, optimize analgesics, involve social work).
• Informed Refusal & Discussion:
  • Explicitly explain the diagnosis, proposed treatment, and specific risks of leaving (including permanent disability or death).
  • Discuss available alternatives (e.g., outpatient parenteral therapy, PO conversion).
• Harm Reduction (Never Punitive):
  • Provide outpatient prescriptions: Switch IV meds to PO equivalents (e.g., oral fluoroquinolones for bacteremia/pyelonephritis).
  • Arrange follow-up: Schedule clinic appointments and outline clear red-flag return precautions.
  • “Open Door” policy: Emphasize they are welcome to return at any time without penalty or judgment.
  • Remove invasive lines: Remove peripheral IVs prior to exit to prevent phlebitis or illicit substance injection.
• Legal & Documentation Essentials:
  • Document DMC assessment, risks explained, alternatives offered, and discharge instructions thoroughly.
  • If the pt refuses to sign the AMA form, document the refusal with a witness (e.g., RN); they must still be allowed to leave (physical detention equals false imprisonment).

Research ethics

• Option A: Informed Consent, NO IRB Approval
  • Standard clinical care: Surgeries, procedures, transfusions.
  • Off-label prescribing: Using an approved drug for an unapproved indication in an individual pt.
  • Emergency single-pt compassionate use: Urgent access to an investigational drug for an acutely dying pt (IRB notified post-hoc within 5 days; FDA emergency clearance needed).
• Option B: Both IRB Approval AND Informed Consent
  • Prospective clinical trials / RCTs: Any experimental drug, device, or interventional protocol.
  • Prospective observational studies: Research-driven blood draws, biopsies, or physical testing on living pts.
  • Vulnerable population research: Pediatrics (parental consent + child assent), pregnant individuals, prisoners.
  • Sensitive identifiable surveys: Research evaluating illicit drug use, psychiatric illness, or sexual history.
• Option C: IRB Approval, NO Informed Consent
  • Retrospective chart reviews: Large-scale EMR data extraction with PHI where obtaining consent is impracticable (requires formal IRB consent waiver). c
  • Emergency Exception from Informed Consent (EFIC): Resuscitation trials for acute life-threats (e.g., cardiac arrest, status epilepticus) where pt lacks capacity and surrogate is unavailable.
  • Secondary use of identifiable biospecimens: Stored tissue/blood linked to pt identifiers.
  • Deception studies: Behavioral research where disclosing the study hypothesis would invalidate results (requires post-study debriefing).
• Option D: NEITHER IRB Approval NOR Informed Consent
  • Quality Improvement (QI) / Quality Assurance (QA): Internal hospital initiatives (e.g., checklist audits, hand-hygiene compliance, central line infection reduction).
  • Public de-identified data: Population registries (e.g., CDC NHANES, SEER database, census data).
  • Completely anonymized biospecimens: Leftover specimens stripped of all 18 HIPAA identifiers with no re-linkable codes.
  • Cadaveric research: Studies on deceased individuals or autopsies.
  • Single-patient case reports: Retrospective descriptions of unique clinical presentations ($\le 3$ pts).