Improving Quality and Safety in the Endoscopy Unit (Virtual) | October 2024-ASGE informed consent guideline

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The American Society for Gastrointestinal Endoscopy (ASGE) has updated its guidelines on informed consent for gastrointestinal (GI) endoscopic procedures. This document focuses on enhancing the informed consent process, rooted in ethical principles of self-determination and autonomy, essential to patient care and legal compliance across all 50 U.S. states. The guidelines emphasize that informed consent should involve a detailed discussion between physicians and patients about the reasons for a procedure, potential benefits, risks, and alternative options. Patients acknowledge consent via a signed form following this discussion.<br /><br />The guidelines are intended to standardize patient care, improve outcomes, and minimize practice variability, while also noting that they do not substitute clinical judgment and may not consider all factors affecting individual patient decisions. They acknowledge that legal requirements may vary by state and advise practitioners to be familiar with local laws.<br /><br />Informed consent can be obtained by medically knowledgeable members of the GI team beyond the treating physician. For direct access endoscopy procedures, informed consent should still be performed and documented prior to the procedure. The guideline supports using electronic resources to enhance patient understanding and details the need to discuss FDA-off-label uses of devices during consent. Exceptions to informed consent include emergencies where obtaining full consent may not be feasible.<br /><br />High-quality informed consent is also necessary for pediatric patients, involving age-appropriate processes and including parental and patient assent wherever possible. The guideline adapts to contemporary team-based medical practice, endorses electronic systems to aid the consent process, and encourages discussions about trainee involvement and potential educational use of patient data.<br /><br />These efforts aim to improve the informed consent experience, aligning with best practices and regulatory standards, while recognizing the evolving legal and medical landscape regarding patient rights and practitioner responsibilities.

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Concept Informed Consent

Concept Autonomy

Concept Disclosure Standards

Concept Risks

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Keywords

ASGE

informed consent

GI endoscopy

patient autonomy

ethical principles

standardize care

electronic resources

legal compliance

pediatric consent

team-based practice

Informed Consent

Autonomy

Disclosure Standards

Risks

Capacity