Informed Consent

What is informed consent and shared decision making? 

Informed consent is a part of both medical ethics and law (though exact wording and definition may vary based on locality). It entails that a medical provider must tell a patient about all potential benefits, risks, alternatives, etc to a medical procedure or course of treatment.

In order to be able to obtain informed consent, we need a few things:

  • Patient who is able to give consent 

  • Presentation of accurate information that includes: 

    • Diagnosis (if it is known) 

    • Nature and purpose of the recommended interventions 

    • The risks, benefits, and alternatives of all options 

  • Documentation of the conversion and the ultimate decision 

Shared decision making is similar, and is also a key component of patient-centered healthcare. It is a process in which clinicians and patients work together to make decisions, selection treatments, that is based both on evidence and balances risks/benefits and patient values 

  • It is not a menu of everything that is available!

Some special situations:

  • Patient that lacks decision-making capacity

    1. Any physician can determine if a patient has capacity!

    2. A brief aside on capacity/competency:

      1. Capacity: a person’s ability to use information they are given and make a choice that is congruent with their own choices and preferences. Law and ethics have settled on four decision-making abilities that constitute it, which are:

        1. Understanding

        2. Expressing a choice

        3. Appreciation

        4. Reasoning.

      2. Competency: a legal judgement that is informed by an assessment of capacity. Basically, whether an individual has the legal right to make their own decisions.

    3.  Times to assess capacity:

      1. Presence of cognitive impairment from any cause.

      2. Circumstance where patient’s decision is inconsistent with prior decision.

    4. How to assess capacity:

      1. Should be done with open-ended questions to basically understand if patient has understanding, expressing a choice, appreciation (recognizing facts and how they are relevant to themselves), and reasoning for their decision 

      2.  There are a few validated instruments out there:

        1. MacArthur Competency Assessment Tool for Treatment 

        2. Assessment of Capacity for Everyday Decisions

        3. Capacity to Consent to Treatment Interview 

    5. Even if the patient is not deemed to have adequate capacity, they should still be engaged in their care as much as possible!

      1. Identify an appropriate surrogate on the patient’s behalf - either through durable power of attorney or through family members.

      2. Sometimes, if there is question to capacity or to a surrogate, or any other questions, may be a reason to consult an ethics board. 

  • Minors

    1. Not considered to have capacity to make healthcare decisions on their own except for a few cases. This varies by situation and by state.

      1. Minors who become pregnant in some states can be considered capable of making their own decisions regarding their care (ie. abortion, epidurals, etc).

    2. Emancipated minors may make their own healthcare decisions in most jursidictions.

  •  Situation that does not require informed consent

    1. Usually: 

      1. Emergency - person is unconscious or in danger of death or serious outcomes (loss of limb) if medical care is not given, then informed consent may not be required 

      2. If there is an advanced directive stating that patient refuses certain types of care 

      3. If there is decision by a court that overrides the patient’s decision