Informed consent is mandatory before an endoscopic procedure. Its purpose is to educate the patient about the procedure and review the associated risks, benefits, and alternatives. Together, the provider and patient can then decide on a plan of action, called shared decision-making. The American Society for Gastrointestinal Endoscopy Standards of Practice Committee has updated its guidance on best practices for informed consent.
There are 2 different legal disclosure standards for informed consent: (1) The physician-based standard requires a physician to disclose to the patient an amount of information that a reasonable, similarly situated physician would provide, and (2) the patient standard requires the medical team to offer information for a reasonable layperson to consider it substantial enough to comprehend and consent to a procedure.
- Endoscopists and practitioners should know which standard of informed consent is required in the state where they practice (strong recommendation, low quality of evidence).
- Informed consent may be obtained by any GI team member well-informed of and able to explain the indication(s), risks, benefits, and alternatives of that procedure (strong recommendation, low quality of evidence). The health care team members authorized to obtain consent vary by state.
- Informed consent should be discussed and documented before a procedure (conditional recommendation, low quality of evidence). Patient recall may be enhanced by supplemental written or video material.
- Off-label techniques and devices not approved by the U.S. Food and Drug Administration should be discussed in the informed consent process (conditional recommendation, low quality of evidence).
- When a patient requires an emergency procedure, every reasonable attempt should be made (and documented) beforehand to obtain written or verbal consent (strong recommendation, high quality of evidence).
- With pediatric patients undergoing GI procedures, consent and assent processes that are developmentally and age-appropriate for patients and their families are recommended (strong recommendation, low quality of evidence). The American Academy of Pediatrics recommends that physicians involve pediatric patients in their health care decision-making.
Vanessa M. Shami, MD, FASGE
COMMENT Endoscopists should not only be familiar with the informed consent process but also the rules particular to their practicing state.
Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
