07. Informed Consent and Refusal

Definition

Informed consent is a shared decision-making process between the patient and physician. It is the disclosure of appropriate information to a patient who is permitted to make a voluntary decision. It is required for invasive or complex procedures and for treatments with significant risk. On the medical ward, this includes blood transfusion or any procedure, including paracentesis, thoracentesis, or lumbar puncture.

Informed consent is a legal and ethical responsibility that protects patient safety and autonomy. In situations in which it is difficult to obtain informed consent (emergencies, low health literacy) or informed refusal (patients leaving AMA, refusing procedures), thorough assessments of capacity, multidisciplinary assistance, and clear documentation are key.

Critical Steps of Informed Consent

  • Assess patient’s capacity for decision-making and communication.
    • Use professional interpreters as available and document their use.
    • Patients with low health literacy, limited English proficiency, or significant illness have more documented difficulties with informed consent.
  • Explain the intervention and risks and benefits. Use plain language and concrete details.
  • Discuss reasonable alternatives (as well as no intervention), along with their risks and benefits.
  • Assess patient understanding. Have the patient “teach-back” to you their understanding.
  • Patient consent and document: 
    • Ask patient to sign a consent form, but consent can be verbal if documented.
    • Remember, simply obtaining a patient’s signature on a consent form does not equate to the patient having given informed consent.
    • Document informed consent in the procedure note. Below is an example: 

Date

Procedure Note

Mr./Ms. ______ was explained the major risks and benefits associated with ______ procedure, and I answered his/her questions. I obtained informed consent directly from the patient in his/her language/through a professional interpreter/through nurse/staff/family member as interpreter. The patient signed a consent form. The patient was then prepped in the usual manner. A “time-out” check was performed. Signature

Emergency Consent

  • Consent may be presumed in emergencies. However, if the situation permits, it is better to take the time to obtain informed consent, collect collaborative information, or use a surrogate decision-maker (see “Decision Making Capacity”). These circumstances must be documented.
  • Informed consent may be obtained by phone. These telephone discussions should be witnessed by a hospital employee and well documented.

Informed Refusal

  • Informed refusal is often as important as informed consent, particularly with patients who may be leaving AMA or placing themselves at danger. Assess capacity to make decisions (see “Decision Making Capacity”) and go through the usual steps of obtaining informed consent.
  • Patients may refuse to receive information if they so choose. Thorough documentation of this event is recommended.
  • Exceptions to informed refusal may include communicable diseases, pregnancy, or attempted suicide during hospitalization.

Leaving Against Medical Advice (AMA)

These patients often have a high rate of readmission, longer subsequent hospitalizations, and worse overall outcomes. Use the following checklist below to assess patients requesting to leave AMA:

  • Capacity: does the patient understand the risks? Does the patient have decision-making capacity (see “Decision Making Capacity”)? If not, the physician may use physical and chemical restraints as needed and call security. Consider a STAT psychiatry consult if you need additional support.
  • Voluntariness: assess for physical, social, emotional, psychiatric or cultural controlling influences. What are the patient’s reasons for leaving (e.g. substance withdrawal, family or socio-economic factors)?
  • Mitigation: attempt multidisciplinary efforts to mitigate controlling influences (e.g. social work, case management, community partners) and use harm reduction approach.
  • Treatment alternatives: assess medically appropriate outpatient treatment alternatives. If patient needs to be discharged on new medications (especially antibiotics), work with the pharmacy to provide a supply of these medications or send prescriptions to an outside pharmacy.
  • Aftercare: encourage and facilitate aftercare and harm reduction strategies (e.g. schedule follow up, prescribe medications). Try to obtain contact information and review return precautions.
  • Documentation: ask the patient to sign an AMA form when possible. Clearly document the event and the AMA discussion with the patient. Ensure that IV access is removed before discharge.
  • Absent without official leave (AWOL) or Elopement: these patients have a high rate of mortality. 
    • Immediately contact the floor nurse, charge nurse, patient care director/coordinator, the security department, hospital police, and risk management.
    • Contact the patient’s home, family members or emergency contact to advise them of the situation and to obtain relevant information.
    • Document the event and complete an incident report.

 

Appelbaum PS. Assessment of patient’s competence to consent to treatment. New England Journal of Medicine. 2007; 357: 1834-1840.

Berger JT. Discharge against medical advice: ethical considerations and professional obligations. J Hosp Med 2008; 5: 403-408

Cassileth BR, Zupkis RV, Sutton-Smith K, et al. Informed consent – why are its goals imperfectly realized?  N Engl J M 1980;302:896-900.

National Quality Forum. Implementing a national voluntary consensus standard for informed consent. 2005.

Meise A, Kuczewski M. Legal and ethical myths about informed consent. Arch Int Med 1996;156:2521-2526.

Rajput V, Bekes CE. Ethical issues in hospitalist medicine. Med Clin N Am 2002;86:869-886.

Sudore RL, Landefeld CS, Williams BA, et al. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med 2006;21:867-73