American Society for Gastrointestinal Endoscopy guideline on informed consent for GI endoscopic procedures

ASGE Standards of Practice Committee

doi:10.1016/j.gie.2021.10.022

American Society for Gastrointestinal Endoscopy guideline on informed consent for GI endoscopic procedures

ASGE Standards of Practice Committee

Medicine - Gastro, Hepatology, Nutrition Division

Research output: Contribution to journal › Article › peer-review

34 Scopus citations

Abstract

Informed consent is the cornerstone of the ethical practice of procedures and treatments in medicine. The purpose of this document from the American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee is to provide an update on best practice of the informed consent process and other issues around informed consent and shared decision-making for endoscopic procedures. The principles of informed consent are based on longstanding legal doctrine. Several new concepts and clinical trials addressing the best practice of informed consent will help guide practitioners of the burgeoning field of GI endoscopic procedures. After a literature review and an iterative discussion and voting process by the ASGE Standards of Practice Committee, this document was produced to update our guidance on informed consent for the practicing endoscopist. Because this document was designed by considering the laws and broad practice of endoscopy in the United States, legal requirements may differ by state and region, and it is the responsibility of the endoscopist, practice managers, and other healthcare organizations to be aware of local laws. Our recommendations are designed to improve the informed consent experience for both physicians and patients as they work together to diagnose and treat GI diseases with endoscopy.

Original language	English (US)
Pages (from-to)	207-215.e2
Journal	Gastrointestinal endoscopy
Volume	95
Issue number	2
DOIs	https://doi.org/10.1016/j.gie.2021.10.022
State	Published - Feb 2022

Bibliographical note

Funding Information:
The following authors disclosed financial relationships: A. C. Storm is a consultant for and has received travel compensation and food and beverage from Apollo Endo Surgery US Inc; is a consultant for Endo-TAGSS and Enterasense; receives data/safety monitoring from Erbe USA Inc and GI Dynamics; and has received research support and food and beverage from Boston Scientific Corporation. D. S. Fishman has received food and beverage from AbbVie, Inc and Boston Scientific Corporation. M. A. Al-Haddad has received a grant, research/teaching support, and food and beverage from Boston Scientific Corporation. S. K. Amateau is a consultant for and has received travel and lodging and food and beverage from Boston Scientific Corporation and Olympus America Inc; is a consultant for and has received food and beverage from Cook Medical LLC; and is a consultant for Endo-Therapeutics, Hemostasis LLC, Merit Medical Systems Inc, and Steris Corporation. J. L. Buxbaum is a consultant for and has received a grant, traveling and lodging, and food and beverage from Olympus America Inc; is a consultant for and received travel and lodging and food and beverage from Boston Scientific Corporation; is a consultant for Eagle Pharmaceuticals, Inc and Cook Incorporated; has received a grant from Medtronic USA, Inc; and has received food and beverage from Covidien LP and AbbVie, Inc. N. Coelho-Prabhu has received food and beverage from Boston Scientific Corporation. C. J. DiMaio is a consultant for and has received travel and lodging and food and beverage from Boston Scientific Corporation; is a consultant for Covidien LP and AbbVie, Inc; has received food and beverage from Cook Medical LLC. S. E. Elhanafi has received food and beverage from Gilead Sciences, Inc, Pfizer Inc, Salix Pharmaceuticals, Olympus America Inc, Lumendi LLC, and Covidien LP. N. Forbes is a consultant for Boston Scientific Corporation, Pentax Medical, and Pendopharm Inc; is on the speaker bureau for and has received research support from Pentax Medical. L. L. Fujii-Lau has received a grant from Cook Medical LLC; has received travel and lodging from Ovesco; and has received food and beverage from Covidien LP and Boston Scientific Corporation. T. L. Jue has received food and beverage from Boston Scientific Corporation. D. R. Kohli has received a grant from Olympus Corporation of the Americas and has received food and beverage from Boston Scientific Corporation. R. S. Kwon has received travel compensation from C2 Therapeutics, Inc and has received food and beverage from Covidien LP. J. K. Law has received food and beverage from Cook Medical LLC. S. Pawa has received educational support from Alexion Pharmaceuticals, Inc and has received food and beverage from Cook Medical LLC. C. N. Thosani is a consultant for and has received travel compensation and food and beverage from Boston Scientific Corporation; is a consultant for TaeWoong Medical; is a consultant and has received research support, travel and lodging, and food and beverage from Pentax of America, Inc; receives royalties from UpToDate; has received research support and food and beverage from Endogastric Solutions; is a speaker for and has received food and beverage from Abbie; has received food and beverage from Covidien, LP; and is on the advisory board for ColubrisMX Inc. S. Wani is a consultant for and has received food and beverage from Boston Scientific Corporation; is a consultant for Medtronic, Exact Sciences, and Interpace; received a grant from Cook Medical LLC; has received food and beverage from Olympus America Inc; and is on the advisory board for Cernostics. B. J. Qumseya has received food and beverage from Boston Scientific Corporation and GlaxoSmithKline, LLC.

Funding Information:
We thank ASGE librarian consultant Ms Kellee Kaulback for her assistance in performing the literature search used in this document as well as Dr Prateek Sharma, Dr Ramzi Mulki, and Dr Jenifer Lightdale for their review of this document.

Publisher Copyright:
© 2022 American Society for Gastrointestinal Endoscopy

Publisher link

10.1016/j.gie.2021.10.022

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title = "American Society for Gastrointestinal Endoscopy guideline on informed consent for GI endoscopic procedures",

abstract = "Informed consent is the cornerstone of the ethical practice of procedures and treatments in medicine. The purpose of this document from the American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee is to provide an update on best practice of the informed consent process and other issues around informed consent and shared decision-making for endoscopic procedures. The principles of informed consent are based on longstanding legal doctrine. Several new concepts and clinical trials addressing the best practice of informed consent will help guide practitioners of the burgeoning field of GI endoscopic procedures. After a literature review and an iterative discussion and voting process by the ASGE Standards of Practice Committee, this document was produced to update our guidance on informed consent for the practicing endoscopist. Because this document was designed by considering the laws and broad practice of endoscopy in the United States, legal requirements may differ by state and region, and it is the responsibility of the endoscopist, practice managers, and other healthcare organizations to be aware of local laws. Our recommendations are designed to improve the informed consent experience for both physicians and patients as they work together to diagnose and treat GI diseases with endoscopy.",

author = "\{ASGE Standards of Practice Committee\} and Storm, \{Andrew C.\} and Fishman, \{Douglas S.\} and Buxbaum, \{James L.\} and Nayantara Coelho-Prabhu and Al-Haddad, \{Mohammad A.\} and Amateau, \{Stuart K.\} and Calderwood, \{Audrey H.\} and DiMaio, \{Christopher J.\} and Elhanafi, \{Sherif E.\} and Nauzer Forbes and Fujii-Lau, \{Larissa L.\} and Jue, \{Terry L.\} and Kohli, \{Divyanshoo R.\} and Kwon, \{Richard S.\} and Law, \{Joanna K.\} and Swati Pawa and Thosani, \{Nirav C.\} and Sachin Wani and Qumseya, \{Bashar J.\}",

note = "Funding Information: The following authors disclosed financial relationships: A. C. Storm is a consultant for and has received travel compensation and food and beverage from Apollo Endo Surgery US Inc; is a consultant for Endo-TAGSS and Enterasense; receives data/safety monitoring from Erbe USA Inc and GI Dynamics; and has received research support and food and beverage from Boston Scientific Corporation. D. S. Fishman has received food and beverage from AbbVie, Inc and Boston Scientific Corporation. M. A. Al-Haddad has received a grant, research/teaching support, and food and beverage from Boston Scientific Corporation. S. K. Amateau is a consultant for and has received travel and lodging and food and beverage from Boston Scientific Corporation and Olympus America Inc; is a consultant for and has received food and beverage from Cook Medical LLC; and is a consultant for Endo-Therapeutics, Hemostasis LLC, Merit Medical Systems Inc, and Steris Corporation. J. L. Buxbaum is a consultant for and has received a grant, traveling and lodging, and food and beverage from Olympus America Inc; is a consultant for and received travel and lodging and food and beverage from Boston Scientific Corporation; is a consultant for Eagle Pharmaceuticals, Inc and Cook Incorporated; has received a grant from Medtronic USA, Inc; and has received food and beverage from Covidien LP and AbbVie, Inc. N. Coelho-Prabhu has received food and beverage from Boston Scientific Corporation. C. J. DiMaio is a consultant for and has received travel and lodging and food and beverage from Boston Scientific Corporation; is a consultant for Covidien LP and AbbVie, Inc; has received food and beverage from Cook Medical LLC. S. E. Elhanafi has received food and beverage from Gilead Sciences, Inc, Pfizer Inc, Salix Pharmaceuticals, Olympus America Inc, Lumendi LLC, and Covidien LP. N. Forbes is a consultant for Boston Scientific Corporation, Pentax Medical, and Pendopharm Inc; is on the speaker bureau for and has received research support from Pentax Medical. L. L. Fujii-Lau has received a grant from Cook Medical LLC; has received travel and lodging from Ovesco; and has received food and beverage from Covidien LP and Boston Scientific Corporation. T. L. Jue has received food and beverage from Boston Scientific Corporation. D. R. Kohli has received a grant from Olympus Corporation of the Americas and has received food and beverage from Boston Scientific Corporation. R. S. Kwon has received travel compensation from C2 Therapeutics, Inc and has received food and beverage from Covidien LP. J. K. Law has received food and beverage from Cook Medical LLC. S. Pawa has received educational support from Alexion Pharmaceuticals, Inc and has received food and beverage from Cook Medical LLC. C. N. Thosani is a consultant for and has received travel compensation and food and beverage from Boston Scientific Corporation; is a consultant for TaeWoong Medical; is a consultant and has received research support, travel and lodging, and food and beverage from Pentax of America, Inc; receives royalties from UpToDate; has received research support and food and beverage from Endogastric Solutions; is a speaker for and has received food and beverage from Abbie; has received food and beverage from Covidien, LP; and is on the advisory board for ColubrisMX Inc. S. Wani is a consultant for and has received food and beverage from Boston Scientific Corporation; is a consultant for Medtronic, Exact Sciences, and Interpace; received a grant from Cook Medical LLC; has received food and beverage from Olympus America Inc; and is on the advisory board for Cernostics. B. J. Qumseya has received food and beverage from Boston Scientific Corporation and GlaxoSmithKline, LLC. Funding Information: We thank ASGE librarian consultant Ms Kellee Kaulback for her assistance in performing the literature search used in this document as well as Dr Prateek Sharma, Dr Ramzi Mulki, and Dr Jenifer Lightdale for their review of this document. Publisher Copyright: {\textcopyright} 2022 American Society for Gastrointestinal Endoscopy",

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month = feb,

doi = "10.1016/j.gie.2021.10.022",

language = "English (US)",

volume = "95",

pages = "207--215.e2",

journal = "Gastrointestinal endoscopy",

issn = "0016-5107",

publisher = "Elsevier Inc.",

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TY - JOUR

T1 - American Society for Gastrointestinal Endoscopy guideline on informed consent for GI endoscopic procedures

AU - ASGE Standards of Practice Committee

AU - Storm, Andrew C.

AU - Fishman, Douglas S.

AU - Buxbaum, James L.

AU - Coelho-Prabhu, Nayantara

AU - Al-Haddad, Mohammad A.

AU - Amateau, Stuart K.

AU - Calderwood, Audrey H.

AU - DiMaio, Christopher J.

AU - Elhanafi, Sherif E.

AU - Forbes, Nauzer

AU - Fujii-Lau, Larissa L.

AU - Jue, Terry L.

AU - Kohli, Divyanshoo R.

AU - Kwon, Richard S.

AU - Law, Joanna K.

AU - Pawa, Swati

AU - Thosani, Nirav C.

AU - Wani, Sachin

AU - Qumseya, Bashar J.

N1 - Funding Information: The following authors disclosed financial relationships: A. C. Storm is a consultant for and has received travel compensation and food and beverage from Apollo Endo Surgery US Inc; is a consultant for Endo-TAGSS and Enterasense; receives data/safety monitoring from Erbe USA Inc and GI Dynamics; and has received research support and food and beverage from Boston Scientific Corporation. D. S. Fishman has received food and beverage from AbbVie, Inc and Boston Scientific Corporation. M. A. Al-Haddad has received a grant, research/teaching support, and food and beverage from Boston Scientific Corporation. S. K. Amateau is a consultant for and has received travel and lodging and food and beverage from Boston Scientific Corporation and Olympus America Inc; is a consultant for and has received food and beverage from Cook Medical LLC; and is a consultant for Endo-Therapeutics, Hemostasis LLC, Merit Medical Systems Inc, and Steris Corporation. J. L. Buxbaum is a consultant for and has received a grant, traveling and lodging, and food and beverage from Olympus America Inc; is a consultant for and received travel and lodging and food and beverage from Boston Scientific Corporation; is a consultant for Eagle Pharmaceuticals, Inc and Cook Incorporated; has received a grant from Medtronic USA, Inc; and has received food and beverage from Covidien LP and AbbVie, Inc. N. Coelho-Prabhu has received food and beverage from Boston Scientific Corporation. C. J. DiMaio is a consultant for and has received travel and lodging and food and beverage from Boston Scientific Corporation; is a consultant for Covidien LP and AbbVie, Inc; has received food and beverage from Cook Medical LLC. S. E. Elhanafi has received food and beverage from Gilead Sciences, Inc, Pfizer Inc, Salix Pharmaceuticals, Olympus America Inc, Lumendi LLC, and Covidien LP. N. Forbes is a consultant for Boston Scientific Corporation, Pentax Medical, and Pendopharm Inc; is on the speaker bureau for and has received research support from Pentax Medical. L. L. Fujii-Lau has received a grant from Cook Medical LLC; has received travel and lodging from Ovesco; and has received food and beverage from Covidien LP and Boston Scientific Corporation. T. L. Jue has received food and beverage from Boston Scientific Corporation. D. R. Kohli has received a grant from Olympus Corporation of the Americas and has received food and beverage from Boston Scientific Corporation. R. S. Kwon has received travel compensation from C2 Therapeutics, Inc and has received food and beverage from Covidien LP. J. K. Law has received food and beverage from Cook Medical LLC. S. Pawa has received educational support from Alexion Pharmaceuticals, Inc and has received food and beverage from Cook Medical LLC. C. N. Thosani is a consultant for and has received travel compensation and food and beverage from Boston Scientific Corporation; is a consultant for TaeWoong Medical; is a consultant and has received research support, travel and lodging, and food and beverage from Pentax of America, Inc; receives royalties from UpToDate; has received research support and food and beverage from Endogastric Solutions; is a speaker for and has received food and beverage from Abbie; has received food and beverage from Covidien, LP; and is on the advisory board for ColubrisMX Inc. S. Wani is a consultant for and has received food and beverage from Boston Scientific Corporation; is a consultant for Medtronic, Exact Sciences, and Interpace; received a grant from Cook Medical LLC; has received food and beverage from Olympus America Inc; and is on the advisory board for Cernostics. B. J. Qumseya has received food and beverage from Boston Scientific Corporation and GlaxoSmithKline, LLC. Funding Information: We thank ASGE librarian consultant Ms Kellee Kaulback for her assistance in performing the literature search used in this document as well as Dr Prateek Sharma, Dr Ramzi Mulki, and Dr Jenifer Lightdale for their review of this document. Publisher Copyright: © 2022 American Society for Gastrointestinal Endoscopy

PY - 2022/2

Y1 - 2022/2

N2 - Informed consent is the cornerstone of the ethical practice of procedures and treatments in medicine. The purpose of this document from the American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee is to provide an update on best practice of the informed consent process and other issues around informed consent and shared decision-making for endoscopic procedures. The principles of informed consent are based on longstanding legal doctrine. Several new concepts and clinical trials addressing the best practice of informed consent will help guide practitioners of the burgeoning field of GI endoscopic procedures. After a literature review and an iterative discussion and voting process by the ASGE Standards of Practice Committee, this document was produced to update our guidance on informed consent for the practicing endoscopist. Because this document was designed by considering the laws and broad practice of endoscopy in the United States, legal requirements may differ by state and region, and it is the responsibility of the endoscopist, practice managers, and other healthcare organizations to be aware of local laws. Our recommendations are designed to improve the informed consent experience for both physicians and patients as they work together to diagnose and treat GI diseases with endoscopy.

AB - Informed consent is the cornerstone of the ethical practice of procedures and treatments in medicine. The purpose of this document from the American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee is to provide an update on best practice of the informed consent process and other issues around informed consent and shared decision-making for endoscopic procedures. The principles of informed consent are based on longstanding legal doctrine. Several new concepts and clinical trials addressing the best practice of informed consent will help guide practitioners of the burgeoning field of GI endoscopic procedures. After a literature review and an iterative discussion and voting process by the ASGE Standards of Practice Committee, this document was produced to update our guidance on informed consent for the practicing endoscopist. Because this document was designed by considering the laws and broad practice of endoscopy in the United States, legal requirements may differ by state and region, and it is the responsibility of the endoscopist, practice managers, and other healthcare organizations to be aware of local laws. Our recommendations are designed to improve the informed consent experience for both physicians and patients as they work together to diagnose and treat GI diseases with endoscopy.

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UR - https://www.scopus.com/pages/publications/85122278201#tab=citedBy

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IS - 2

ER -

American Society for Gastrointestinal Endoscopy guideline on informed consent for GI endoscopic procedures

Abstract

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