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