Dear Editor,
Informed consent is a legal and ethical mandate before endoscopic procedures are initiated. The American Society of Gastrointestinal Endoscopy has issued guidelines on what constitutes appropriate informed consent, specifying information to be disclosed, personnel who should obtain consent, documentation, and the timing and setting of informed consent (Zuckerman et al., and Standards of Practice Committee, 2007). In reference to the timing of obtaining informed consent, the guidelines simply state that "informed consent must be obtained within a reasonable time before the procedure is performed." They acknowledge that with the increasing use of open access endoscopy (OAE), it is not possible to consent patients during an office visit before each procedure and that the discussion with the patient depends on the details of each case (Zuckerman et al., and Standards of Practice Committee, 2007). The guidelines encompass the essence of informed consent but leave ambiguity regarding 2 specific points. First, what constitutes a reasonable time before endoscopy? Second, does it matter where the patient is consented?
Reasonable time has been arbitrarily defined by a few as at least 24 hours before the procedure (Sidhu, Sakellariou, Layte, & Soliman, 2006). The thought is that this allows patients sufficient time to deliberate and thus fully understand the procedure they are consenting to. It has also been argued that although patients can consent at the time of procedure, the time and effort already invested in scheduling and preparing for the procedure may bias the patient to proceed with the procedure (Staff et al., 2000). Unfortunately, an additional office visit to discuss the procedure negates the advantages of OAE such as expedited scheduling of procedures and improved resource utilization. It has now become common practice to obtain informed consent from patients on the day of the procedure. A study by Proctor et al. showed that patients consented 10-60 minutes before endoscopy had similar recall compared with patients' consented 48-72 hours before (Proctor, Price, Minhas, Gumber, & Christie, 1999). One recommended way to mitigate the risk that the patients may not have adequate time to process information about the procedure is to mail information packets to patients beforehand (Zuckerman et al., and Standards of Practice Committee, 2007).
If we accept that consenting patients on the day of procedure meets our ethical and legal standards, the next question to tackle is whether the location of informed consent matters; specifically, in the preoperative area as compared with the procedure room? From a work-flow efficiency perspective, obtaining informed consent in the procedure room is clearly preferred but endoscopy units may be hesitant to do so because of concerns about meeting regulatory requirements. At random, we contacted managers or directors of 40 hospital-based endoscopy units in the United States performing OAE, and asked them where consent takes place at their institution. Twenty-six of 40 endoscopy units consented most patients in the procedure room. The remaining 14 units obtained consent upon patient arrival to the endoscopy unit or in the pre-procedure area. Interestingly, of the 14 units that did not consent patients in the procedure room, directors at eight of these institutions believed that this was per regulatory requirement from hospital accreditation agencies. Furthermore, most felt that having the option of consenting patients in the procedure room would simplify the consent process and improve efficiency. We contacted one hospital accreditation agency, The Joint Commission, and were told that there is no specific regulation regarding where and when informed consent is obtained, as long as it is performed before the procedure.
Ultimately, it is up to each facility to determine their informed consent protocol, but avoidance of intraprocedure room consent should not be due to concern about regulatory, legal, or ethical requirements.
Omair Atiq, MD
Clinical Fellow
Department of Internal Medicine
Division of Digestive and Liver Diseases
University of Texas, Southwestern Medical Center, Dallas
Nisa Kubiliun, MD
Assistant Professor
Department of Internal Medicine
Division of Digestive and Liver Disease
University of Texas, Southwestern Medical Center,
Dallas
Deepak Agrawal, MD
Assistant Professor
Department of Internal Medicine
Division of Digestive and Liver Disease
University of Texas, Southwestern Medical Center,
Dallas
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