Guidance covering informed consent in endoscopy has been refined in the UK following the obstetric case of Nadine Montgomery, and in light of updated General Medical Council guidance. All risks likely to be material to the patient must be explored, as well as alternatives to the procedure. Despite this, departments and endoscopists still struggle to meet the current standards. In this article, we explore the challenges encountered in achieving individualised consent in therapeutic endoscopy through real-life scenarios.

Five realistic therapeutic endoscopy (hepatobiliary) scenarios are described, followed by presentation of possible or ideal approaches, with references related to existing literature in this field.

The vignettes allow consideration of how to approach difficult consent challenges, including anxiety and information overload, urgency during acute illness, failure to disclose the risk of death, the role of trainees and intraprocedural distress under conscious sedation.

The authors conclude that a high degree of transparency is required while obtaining consent for therapeutic endoscopy accompanied by full documentation, involvement of relatives in nearly all cases, and clarity around the presence of trainees who may handle the scope. A greater focus on upskilling trainees in the consent process for therapeutic endoscopy is required.

With medical litigation on the rise, physicians require a nuanced understanding of the legalities of consenting patients to reduce their liability while practising evidence-based medicine. This study aims to a) clarify the legal duties of gastroenterologists in the UK and USA when gaining informed consent and b) provide recommendations at the international and physician level to improve the consent process and reduce liability.A bibliometric analysis of the Web of Science database with the MeSH terms "gastroenterology" and "informed consent" yielded 383 articles, of which 228 were excluded due to not meeting the inclusion criteria. Of the top 50 articles, 48% were from American institutions and 16% were from the UK. Thematic analysis showed 72% of the articles discussed informed consent in relation to diagnostic procedures, 14% regarding treatment, and 14% regarding research participation.Both the USA and the UK have progressed from previously paternalistic Natanson case (1960) and Bolam test (1957), respectively, where physicians were held to the standard of a "reasonable and prudent medical doctor". The American Canterbury case (1972) and the British Montgomery case (2015) radically shifted the standard of disclosure during the consent process by requiring physicians to explain all information pertinent to a "reasonable patient".It is our recommendation that a two-pronged approach be taken; a) creation of international guidelines for consenting patients for invasive procedures in gastroenterology, and b) development of internationally standardised endoscopy consent forms containing all the details pertinent to a "reasonable patient".

All endoscopic procedures are invasive and carry risk. Accordingly, all endoscopists should involve the patient in the decision-making process about the most appropriate endoscopic procedure for that individual, in keeping with a patient's right to self-determination and autonomy. Recognition of this has led to detailed guidelines on informed consent for endoscopy in some countries, but in many no such guidance exists; this may lead to variations in care and exposure to risk of litigation. In this document, the European Society of Gastrointestinal Endoscopy (ESGE) sets out a series of statements that cover best practice in informed consent for endoscopy. These statements should be seen as a minimum standard of practice, but practitioners must be aware of and adhere to the law in their own country. 1:  Patients should give informed consent for all gastrointestinal endoscopic procedures for which they have capacity to do so. 2:  The healthcare professional seeking consent for an endoscopic procedure should ensure that the patient has the capacity to consent to that procedure. 3:  For patients who lack capacity, healthcare personnel should at all times try to engage with people close to the patient, such as family, friends, or caregivers, to achieve consensus on the appropriateness of performing the procedure. 4:  Where a patient lacks capacity to provide informed consent, the best interest decision should be clearly documented in the medical record. This should include information about the capacity assessment, reason(s) that the decision cannot be delayed for capacity recovery (or if recovery is not expected), who has been consulted, and where relevant the form of authority for the decision. 5:  There should be a systematic and transparent disclosure of the expected benefits and harms that may reasonably affect patient choice on whether or not to undergo any diagnostic or interventional endoscopic procedure. Information about possible alternatives, as well as the consequences of doing nothing, should also be provided when relevant. 6:  The information provided on the benefit and harms of an endoscopic procedure should be adapted to the procedure and patient-specific risk factors, and the preferences of the patient should be central to the consent process. 7:  The consent discussion should be undertaken by an individual who is familiar with the procedure and its risks, and is able to discuss these in the context of the individual patient. 8:  Patients should confirm consent to an endoscopic procedure in a private, unrushed, and non-coercive environment. 9:  If a patient requests that an endoscopic procedure be discontinued, the procedure should be paused and the patient's capacity for decision making assessed. If a competent patient continues to object to the procedure, or if a conclusive determination of capacity is not feasible, the examination should be terminated as soon as it is safe to do so. 10: Informed consent should be sufficiently detailed to cover all findings that can be reasonably anticipated during an endoscopic examination. The scope of this consent should not be expanded, nor a patient's implicit consent for additional interventions assumed, unless failure to proceed with such interventions would result in immediate and predictable harm to the patient.

The manner in which informed consent is obtained varies. The aim of this study is to evaluate the level of knowledge about colonoscopy and comparing 2 methods of obtaining informed consent.

A comparative, cross-sectional, observational study was conducted on patients that underwent colonoscopy in a public hospital (Group A) and in a private hospital (Group B). Group A received information verbally from a physician, as well as in the form of printed material, and Group B only received printed material. A telephone survey was carried out one or 2 weeks later.

The study included a total of 176 subjects (group A [n=55] and group B [n=121]). As regards education level, 69.88% (n=123) of the patients had completed university education, 23.29% (n= 41) secondary level, 5.68% (n=10) primary level, and the remaining subjects (n=2) had not completed any level of education. All (100%) of the subjects knew the characteristics of the procedure, and 99.43% were aware of its benefits. A total of 97.7% received information about complications, 93.7% named some of them, and 25% (n=44) remembered major complications. All the subjects received, read, and signed the informed consent statement before the study. There were no differences between the groups with respect to knowledge of the characteristics and benefits of the procedure, or the receipt and reading of the consent form. Group B responded better in relation to complications (P=.0027) and group A had a better recollection of the major complications (P<.0001). Group A had a higher number of affirmative answers (P<.0001).

The combination of verbal and written information provides the patient with a more comprehensive level of knowledge about the procedure.

Informed consent is legally and ethically required before a patient undergoes an endoscopic procedure, yet current literature suggests that patient comprehension of key components of informed consent is poor.

To evaluate specific aspects of and patient satisfaction with the informed consent process in patients who attended an endoscopy education class versus gastroenterology clinic.

Prospective survey that examined all components of the informed consent process.

Safety-net hospital.

Outpatients undergoing endoscopy.

Endoscopy education class versus gastroenterology clinic.

Patient recall of the components of and satisfaction with the informed consent process.

A total of 301 patients completed the survey, 52.0% of whom attended and were consented in an endoscopy education class. Patients who attended an endoscopy education class reported that a greater number of individual components of the informed consent process were explained to them as compared with patients who were consented in clinic. In multivariate analysis, patients who attended an education class were more likely to recall having had the alternatives (odds ratio [OR] 4.8; 95% confidence interval [CI], 2.0-11.8), details of the procedure (OR 3.0; 95% CI, 1.3-6.8), and what to expect after the procedure (OR 3.0; 95% CI, 1.5-5.6) explained to them by a provider. These patients were more likely to know they could refuse the procedure (OR 4.1; 95% CI, 1.0-16.8), compared with patients consented in the gastroenterology clinic.

Non-randomized trial.

Patients from a diverse, urban population who attended a multilingual endoscopy education class reported having more elements of the informed consent process explained to them compared with patients who were consented in gastroenterology clinic.

Since the 1960s quality assurance has become an integral part of medicine and nursing. The aims of quality assurance cover patient and staff safety and satisfaction, economical factors and the implementation of health care policy. Endoscopy units can be established in hospitals, primary care or ambulatory endoscopy centres. The quality of endoscopy facilities should be the same irrespective where endoscopy is carried out. Endoscopy staff is responsible for individualised, comprehensive patient care, technical assistance including reprocessing, documentation and management of endoscopy units. Quality criteria for endoscopy nursing cover pre, intra and post procedure care. However, a complete separation between clinical medical and nursing outcome criteria is often difficult in Endoscopy, as the clinical interventions are a combination of both medical and nursing actions. It is the combined effort of all staff with the support from the health care provider that leads to a high quality of patient care in Endoscopy.

Only a few reports have examined informed consent for gastrointestinal endoscopy in Korea. The aim of this study was to evaluate the appropriateness of the informed consent procedure in Korea.

A total of 209 patients who underwent endoscopy were asked to answer a self-administered structured questionnaire on the informed consent procedure for gastrointestinal endoscopy.

One hundred thirteen patients completed questionnaires and were enrolled. In the survey, 91.2% answered that they understood the procedure, and the degree of understanding decreased with age; 85.8% were informed of the risks of the procedure, and the proportion was higher for inpatients and for those receiving therapeutic endoscopy or endoscopic retrograde cholangiopancreatography; 60.2% were informed of alternative methods, and the proportion was higher in older patients; 76.1% had the opportunity to ask questions during the informed consent procedure, and the proportion was higher in inpatients. The understanding of the risks of the endoscopic procedure was better in the younger and more highly educated groups. About 80% had sedation before endoscopy, and only 56% were informed of the risks of sedation during endoscopy.

The current informed consent process may be reasonably acceptable and understandable to the patients. However, the understanding of the risks of endoscopy was insufficient especially in the cases of older, poorly educated patients and outpatients. The information about alternatives, the opportunity to ask for additional information, and the information about the risks of sedation during endoscopy were also insufficient in the current consent process.

A thorough and efficient pre-procedure evaluation of the patient's readiness to undergo sedation for endoscopy is essential. This evaluation will allow the formulation of an appropriate sedation plan for the patient, resulting in a safe and effective examination. The post procedure assessment of the patient confirms readiness for discharge and allows for appropriate patient education and follow-up planning.

Endoscopic retrograde cholangiopancreatography (ERCP) is a skill and technique demanding high-risk procedure with an overall complication rate of about 5-10%. Pancreatitis remains the most common complication of ERCP, however, bleeding after sphincterotomies, infections and cardiopulmonary complications as well as perforations may also occur. Patient- and procedure-related risk factors of ERCP complications are mainly predictable so that ERCP often can be avoided and substituted for alternative imaging techniques, especially in high-risk patients. Written consent should be obtained for any ERCP to provide documentary evidence that explanation of the proposed procedure and endoscopic treatment was given and that consent was sought and obtained. The investigating doctor remains responsible for ensuring sufficient time for the patient's questions and to make informed decision before the start of any procedure. The most common legal consequence of an ERCP complication is a civil negligence claim for compensation, however, a clinician may in rare cases be faced with criminal proceedings where there is evidence of gross negligence. Analysis of claims against gastroenterologists suggests the conclusion that ERCP should be done for good indications, by trained endoscopists with standard techniques, with good, documented, patient-informed consent and communication before and after the procedure.

There are many differences and deficiencies in the process of informed consent. The aim of this study was to get the view of gastrointestinal endoscopists in Croatia on obtaining patients' consent before endoscopic procedures.

During the 2004 annual meeting of the Croatian Society of Gastroenterology, endoscopists were asked to answer a questionnaire according to common clinical practice in affiliated institutions. It included questions on endoscopists' experience and education in medical ethics, as well as on the nature and quality of information given to patients and their opinion on proposed measures for improvement of the informed consent process.

The questionnaire was distributed to 96 endoscopists attending the meeting and the response rate was 54% (52/96). In only 50% of institutions was the obtained consent written and potential complications of endoscopic procedures are occasionally given to the patient. In the minority of cases the patient is provided with information about alternative diagnostic tests and/or treatment options, and the information about mortality rate was almost never discussed.

In Croatia, the process of informed consent for endoscopy needs improvement and should be regarded against the background of education in medical ethics, regional burden in endoscopic practice and appropriateness of by-laws and local guidelines.

The purpose of the present paper was to determine informed consent practices for inpatient, open-access colonoscopy and endoscopic retrograde cholangiopancreatography (ERCP) at a tertiary referral center.

A two-part prospective study incorporating (i) an audit of consent practices for colonoscopy and ERCP; and (ii) a questionnaire directed at gastroenterologists and interns regarding information imparted to patients in the process of acquiring informed consent, was undertaken at Sir Charles Gairdner Hospital, Western Australia. Study subjects consisted of inpatients undergoing open-access colonoscopy and/or ERCP at the study center commencing May 2003; and gastroenterologists and interns at the study center.

Written consent was obtained by junior medical staff in 89% of cases. Response rates for the questionnaire was 100% from interns, and 91% from gastroenterologists. Of interns surveyed, 93% had witnessed a colonoscopy, and 59% had witnessed an ERCP. For 12% of interns, colonoscopic bleeding or perforation were not always mentioned. Colonoscopy failure rate and perforation were overestimated by 51% and 63% of interns, respectively. Only 56% of interns always mentioned pancreatitis as a complication of ERCP. The rate of post-ERCP pancreatitis was overestimated by 25% of interns. Only 40% of gastroenterologists always provided additional information to patients whose consent was obtained by someone else. Written material was not routinely provided for patients. Consent was usually obtained on the day of the procedure.

Written consent for inpatients undergoing open-access colonoscopy and ERCP is rarely obtained by the proceduralist. There is substantial variability in the information provided to patients. Guidelines are required to ensure best practice in this area.

This study reports the analysis of a personal series of 59 cases in which ERCP malpractice was alleged.

Half of the cases involved pancreatitis; 16 suffered perforation after sphincterotomy (8 of which involved pre-cutting), and 10 had severe biliary infection. There were 2 esophageal perforations. Fifteen of the patients died. The most common allegation (54% of cases) was that the ERCP, or the therapeutic procedure, was not indicated. Most of these patients had pain only, usually after cholecystectomy. Negligent performance was alleged in 19 cases, with corroborating evidence in 8. Inadequate postprocedure care was alleged in 5 cases, including 3 with a delayed diagnosis of perforation. Disputes about the extent of the education and consent process were common.

The final outcome was available in 40 cases. Sixteen were withdrawn, and 14 were settled. Of the 10 that came to trial, half were defense verdicts.

The lessons are clear. ERCP should be done for good indications, by trained endoscopists with standard techniques, with good documented patient informed consent and communication before and after the procedure. Speculative ERCP, sphincterotomy, and pre-cuts are high-risk for patients and for practitioners.

Doctors and other health professionals should always offer information to patients about the risks, benefits and alternatives to the treatment or examination proposed. Such information should be offered in a timely fashion and in a form understandable to the patient. The professional should assess the patients' ability to comprehend and to make a judgement if their consent is to be valid. Patients occasionally may refuse the offer, but this refusal does not exonerate the doctor from pointing out serious hazards. Discussions of risk must be made in a friendly manner and the patient's questions invited.