Informed consent documentation

Background

• In the ED, consent may be verbal or written depending on procedure risk and institutional policy
• Implied consent applies to emergency, life-saving procedures when the patient lacks capacity and no surrogate is available
• A patient must have decision-making capacity (not the same as legal competence) to provide valid consent
• Consent is a process, not just a form — the discussion matters more than the signature

Elements of Valid Informed Consent

• Nature of the procedure — what will be done, in understandable language
• Indications — why the procedure is recommended
• Risks — common risks AND rare but serious risks (e.g., bleeding, infection, nerve injury, death)
• Benefits — expected outcomes
• Alternatives — including the option of no intervention
• Questions — opportunity for the patient to ask questions
• Document that patient understood and agreed to proceed

Exceptions to Informed Consent

• Emergency exception — life-threatening condition, patient lacks capacity, no surrogate available
• Implied consent — patient presents for care and cooperates with minor interventions
• Therapeutic privilege — rarely invoked; information withheld if disclosure would seriously harm the patient
• Patient waiver — patient explicitly waives right to be informed

Consent for Minors

• Generally requires consent from parent or legal guardian
• Exceptions vary by state but commonly include:
  • Emancipated minors (married, military, court-ordered)
  • Mature minor doctrine (jurisdiction-dependent)
  • Emergency care
  • Reproductive health, STI testing/treatment, substance abuse treatment (state-dependent)

Capacity Assessment

• Four components of decision-making capacity. The patient must be able to:
  • Understand the relevant information
  • Appreciate the situation and consequences
  • Reason through options
  • Communicate a choice
• Capacity is task-specific
  • A patient may have capacity for one decision but not another
• Capacity can fluctuate (e.g., intoxication, delirium)
• If capacity is uncertain, err on the side of treatment in emergencies
• See also Against medical advice for capacity documentation in the AMA context

Sample Documentation

Standard Procedural Consent

Informed consent obtained from @NAME@. The procedure (_____), including the indications, risks (including but not limited to bleeding, infection, pain, nerve/vessel injury, need for further intervention, and _____), benefits, and alternatives (including no intervention) were discussed in language the patient could understand. The patient was given the opportunity to ask questions, which were answered to their satisfaction. The patient expressed understanding and agreed to proceed with the procedure.

Emergency Consent (Patient Lacks Capacity)

The patient requires emergent _____ for _____. The patient is unable to provide informed consent due to ___ (altered mental status, intubation, cardiac arrest, etc.). No surrogate decision maker is immediately available. Given the emergent, life-threatening nature of the condition, the procedure was performed under implied/emergency consent in the patient's best interest per the emergency exception doctrine.

Consent via Surrogate

@NAME@ lacks decision-making capacity due to _____. Informed consent was obtained from _____ (relationship: _____), who is the patient's healthcare proxy/next of kin/legal guardian. The procedure, risks, benefits, and alternatives were discussed. The surrogate expressed understanding and provided consent on the patient's behalf.

See Also

Documentation Pages

• General
  • Documentation for emergency physicians
  • Billing
• Components of the Medical Record
  • Review of systems documentation
  • Physical exam documentation
  • Differential diagnosis documentation
  • MDM for different chief complaints
  • MDM for different chief complaints (peds)
• Procedure and Reexamination
  • Procedure sample documentation
  • Reexamination sample documentation
• Special Documentation
  • Critical care documentation
  • Observation documentation
  • Against medical advice
  • Discharge documentation
  • Death documentation
  • Informed consent documentation
• Reference
  • Ophthalmology abbreviations