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. 2021 Mar 12;31(3):337–386. doi: 10.1089/thy.2020.0944

Table 4.

Informed Consent Checklist

The three components of informed consent involve disclosure, decision-making capacity, and voluntariness
Disclosure
 Truthful prognostication
  Treatment options available and all associated side-effects, ranging from aggressive treatment to palliative care and hospice, including the option of medical assistance in dying.
 Consent for treatment
  Discuss advance directives, code status, and naming a surrogate decision maker.
   Surgical management
    • Surgical candidacy and expected benefits and risks
    • Discussion of intubation and tracheostomy
   Drug therapies
    • Candidacy and contraindications
    • Costs and expected benefit ratio
    • Expected side-effects and rare side-effects
    • When to stop the drug if risks outweigh benefits
   External beam radiation
    • Candidacy and contraindications
    • All side-effects and palliation of side-effects
    • When to stop radiation if risks outweigh benefits
Decision-making capacitya
 After the disclosure discussion, do a “teach back” with the following questions to assess U-ARE
  • What do you understand about your situation?
  • What are your treatment options?
  • What will happen when you take/do not take this treatment?
  • Why do you want/not want it?
  • What other choices do you have?
  • How did you arrive at your choice?
  • What questions do you have?
  •What are you worried about?
Voluntariness
 Discuss with patient a decision-making model that works best, which can include shared decision-making or nondirective counseling about options. If there are concerns that the patient is being coerced into an option, consider speaking to patient alone or having a family meeting, or request a clinical ethics consultation to help assess patient's preferred options.
 Consent for comfort care/hospice
  For patients who opt for comfort care and hospice, all discussions should include a palliative care service or expert, as well as pastoral care to plan an appropriate regimen for the patient. Discussions surrounding palliative surgery and palliative radiation must disclose all risks, benefits, and costs.
a

If you have concerns that your patient does not have decision-making capacity, request a formal capacity assessment with a mental health provider, or request a clinical ethics consultation at your institution. If the patient requires a surrogate decision maker and does not have an advance directive or a court-appointed guardian, consult your state surrogacy laws, which may involve family hierarchy laws, or consult your institutional legal office.

U-ARE, Understanding (U), Appreciation (A), Rationality (R) and ability to Express a choice (E).