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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

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

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