GuidelineInformed consent for GI endoscopy
Section snippets
Definition of informed consent
Consent is defined as the voluntary agreement by a person with the functional capacity for decision making to make an informed choice about allowing an action proposed by another person (eg, performance of a procedure) to be performed on himself or herself.9 Informed consent is defined as a physician's legal requirement to disclose information to his or her patient and enables the patient to understand, evaluate, and authorize a specific surgical or medical intervention.9 The crux of informed
Information to be disclosed
The essential elements of disclosure under either standard include the following:
- 1.
The patient's pertinent medical diagnosis and test results.
- 2.
The nature of the proposed procedure.
- 3.
The reason the procedure is being suggested.
- 4.
The benefits of the procedure.
- 5.
The risks and complications of the procedure, including the relative incidence and severity, that would be material to the patient's decision-making process.
- 6.
Reasonable alternatives to the proposed procedure.
- 7.
The patient's prognosis if the treatment
Personnel to obtain informed consent
The endoscopist is best advised to obtain the patient's informed consent personally.10, 11, 12 In general, this duty should not be delegated to health care providers not directly involved with the procedure, although policies may vary from state to state and from hospital to hospital. It must be emphasized that the purpose of the informed consent process is not simply the acquisition of a patient's or family member's signature but to provide information and ensure that the patient consents,
Documentation of informed consent
Most hospitals require written documentation of consent (eg, a consent form) to satisfy their informed consent policies, although such documentation is required by law in only a few states. The endoscopist must be mindful of the fact that informed consent is a process of disclosure and deliberation, not merely the signing of a form. The typical generic consent form serves little useful purpose other than to provide evidence that the patient signed it. To document the informed consent process,
Timing and setting of informed consent
With few exceptions, noted below, informed consent must be obtained within a reasonable time before the procedure is performed, in outpatient or inpatient settings. The timing of the discussion with the patient and the patient's written acknowledgment will depend on the circumstances of each case. The use of open access endoscopy (OAE) is increasing.28 OAE does not readily allow the provision of preprocedure education and informed consent during an office visit before the endoscopy. Studies
Exceptions to the informed consent process
There are recognized exceptions to the informed consent process that affect an endoscopist's approach to informed consent. These include emergency, therapeutic privilege, waiver, and legal mandate.
Incompetent or incapacitated patients
The quality of informed consent can be affected by multiple factors. A systematic review of the published literature on informed consent found that older age and less formal education were associated with impaired understanding of informed consent information.33 Elderly patients, patients with a below-average IQ, and those with impaired cognitive functions were shown, in a prospective survey of surgical patients, to have poor information recall. Written information given to patients before
Summary (Level of evidence)
- •
The crux of informed consent is a combination of disclosure and voluntary decision making (grade 3).
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The essential elements of adequate disclosure are the nature of a proposed procedure or treatment, the reason the procedure is suggested, the material risks and benefits, and the reasonable alternatives to the proposed procedure (grade 3).
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The endoscopist should be certain to document that the patient's informed consent has been obtained before the performance of a procedure (grade 3).
- •
All informed
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2022, Techniques and Innovations in Gastrointestinal EndoscopyCitation Excerpt :If consent is obtained prior to the day of the procedure, as could be the case for practices with closed endoscopy access, local guidance must be followed to ensure that the informed consent remains valid from the time it is obtained to the day of the procedure. Furthermore, the informed consent should be obtained by the endoscopist directly or an authorized provider who is directly involved in the patient's care.7 If a patient is unable to provide informed consent, efforts to obtain consent from the surrogate must be made prior to the procedure.
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This document is a product of the Standards of Practice Committee. The document was reviewed and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy.