Informed Consent and Shared Decision Making

Informed Consent

• Informed consent- process of getting someone’s permission to receive a medical intervention/participate in research
  • It’s ongoing- they might get more information about treatment/study, change their mind
  • new information may also come to light
• 3 components of informed consent
  • Disclosure- they’re given all information needed to make an informed choice
  • Concerns
    • Information needs to be comprehensible at their level
    • How much information should be given?
  • Capacity- they have ability to understand information and make reasoned judgment about whether or not to agree
  • Voluntariness- they’re free to choose without any coercion/manipulation from family members, physicians, researchers, socioeconomic factors
• Information needed for informed consent
  • Why treatment/study is being done
  • Each step of treatment/study
  • Benefits & risks (benefit can’t be compensation)
  • Any compensation (only applies for research)
  • How to withdraw
• Also need to tell them what is not known if applicable
• Need capacity to have informed consent
  • But legal guardians can consent on their behalf
  • If they have some capacity, their opinions are considered
• How is informed consent gathered?
  • Written document with signature
  • Verbal
  • Only for low-risk situations
  • Can be documented
• Assent- agreement to participate by someone under 18 because they can’t legally consent
  • Informed consent still needs to be given by guardians
  • But assent is important because it acknowledges adolescents’ ability to make decisions
• Emergency situations where patient is unable to give informed consent
  • Use surrogate
  • If no surrogate- medical team makes best judgment abt what patient would want
  • Assumption is usually made that they would want all treatment
• Differs across contexts
  • Eastern cultures may emphasize “family informed consent”
  • Low literacy areas = inability to document consent
  • Consider language fluency of people reading documents
• Overall purpose of informed consent
  • Protection of human rights
  • Educates patient’s/participants about what they’re agreeing to
  • Communication between clinicians/researchers & patients/participants

Shared Decision Making

• Shared decision making- collaborative process of determining course of care between patients and clinicians
  • Patient needs capacity to participate
  • Honors autonomy
• Resists paternalism
• Clinicians educate patients on
  • Available treatment options
  • Pros and cons of those options
• Clinician retains right to refuse to provide the treatment patient is requesting based on
  • If they don’t believe treatment will be beneficial/effective
  • They aren’t trained to provide this treatment (out of scope of practice)
  • They have moral objections to providing this treatment
  • Limits to this- can’t deny care to someone based on race, gender, sexual orientation
• Barriers to shared decision making
  • Time- clinicians have little time w/ patients, not all options can be discussed
  • Expertise- clinician may not know abt every possibility/new options
  • Rapport- patients may not trust clinicians to help them make decisions
  • Patient may prefer paternalistic approach
  • Some patients may not have educational background to help them understand info
  • Language barriers between patient and provider
  • Clinician may not fully understand patient’s values