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ASGE guideline_informed consent
ASGE guideline_informed consent
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The American Society for Gastrointestinal Endoscopy (ASGE) updated its 2022 guideline on best practices for obtaining informed consent for GI endoscopic procedures. Informed consent is an ethical and legal prerequisite rooted in patient self-determination and autonomy, requiring providers to educate patients on the procedure’s indication, benefits, risks (common and serious), alternatives (including no procedure), and potential consequences of refusal. This is followed by the patient agreeing by signature or verbal consent.<br /><br />Key recommendations include: endoscopists should understand local and state legal standards—either a “professional disclosure” (information a reasonable physician would provide) or a “reasonable patient” standard (information a reasonable patient would want). Consent may be obtained not only by the performing physician but by any knowledgeable member of the GI care team (nurses, trainees, advanced practice providers), as long as they can explain procedure indications, risks, benefits, and alternatives. Routine informed consent should be documented before procedures, including in direct-access endoscopy, although timing and setting may vary.<br /><br />Use of electronic and video supplemental materials improves patient recall and understanding and is strongly recommended when available. Informed consent discussions should include disclosure of off-label or non–FDA-approved devices and techniques, with clear explanation of benefits and risks, despite limited data on adverse events for such use.<br /><br />Exceptions to informed consent exist in true emergencies where obtaining written consent may not be feasible; in such cases, efforts should still be made and documented to obtain verbal or proxy consent. Therapeutic privilege (withholding information to protect patients) is rarely appropriate in endoscopy. Patients may waive consent but must do so voluntarily and with clear understanding.<br /><br />In pediatrics, consent legally rests with parents/surrogates; however, age-appropriate assent of minors is encouraged to involve them in decision-making. Special considerations apply based on state laws including mature minor and emancipated minor statutes.<br /><br />The guideline also discusses issues related to incapacitated patients, withdrawal or refusal of consent, interpreter use for non–English-speaking patients, and disclosure of trainee involvement and use of procedure images/videos for education.<br /><br />Overall, the guideline aims to improve patient-physician shared decision-making, standardize informed consent practices, enhance patient understanding and satisfaction, and reduce legal risk for providers. Due to state-by-state legal differences, clinicians must be aware of local requirements. The recommendations balance ethical, medicolegal, and practical aspects of consent in modern GI endoscopic practice.
Keywords
ASGE guidelines
informed consent
GI endoscopy
patient autonomy
legal standards
procedure risks
electronic consent materials
emergency exceptions
pediatric consent
shared decision-making
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