II. Definitions

  1. Informed Consent
    1. Patient willingly participates in medical therapy
    2. Requires understanding what is involved with the proposed therapy
  2. Personal Autonomy
    1. Given capacity, patients may make medical decisions for themselves
    2. Patients are given adequate information about their condition and treatment options to make an informed decision
  3. Beneficence
    1. Medical care given provides more benefit than harm
  4. Nonmaleficence
    1. Avoiding both intentional and unintentional harm to patients
  5. Social Justice
    1. Medical professional duty to promote fair health care resource allocation and delivery

III. Protocol: Requirements for valid Informed Consent

  1. Informed Consent should be obtained by the provider performing the procedure
  2. Patient (or their proxy) must have Medical Decision-Making Capacity
    1. See Medical Decision-Making Capacity
    2. See CURVES Mnemonic for Capacity Assessment
    3. Communicates choices
    4. Understands relevant information
    5. Reasons with logical, rational choices
    6. Values of patients are consistent with their choices
  3. Patient must be given sufficient information including treatment risks and benefits
  4. Patient makes decision without coercion and with adequate information about alternatives to proposed procedure
  5. Decision must be stable over time with the patient likely to consistently make the same decision if asked a second time

IV. Protocol: Criteria for treating a patient without Informed Consent (all must be present)

  1. Patient does not have adequate Decision-Making Capacity (e.g. unconscious or Delirium) AND
  2. No surrogate decision maker or legal document is available AND
  3. Situation is true emergency with threat to life or limb

V. Protocol: Approach to documentation

  1. See Medical Documentation
  2. Obtain written Informed Consent for procedures including contingency plans and document that consent was obtained
  3. Document patient refusal of recommended important clinical interventions in high risk conditions
    1. Obtain signature for refusal Against Medical Advice

VI. References

  1. Seeyave, Sherman and Ward (2020) Crit Dec Emerg Med 34(1): 19-25
  2. Weinstock and Henry in Herbert (2018) EM:Rap 18(1): 19-21
  3. Bradford-Saffles and Arambasick (2013) Crit Dec Emerg Med 27(6): 11-5
  4. Henry (2013) Avoid Being Sued, EM Bootcamp, CEME

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