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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