The evolution of informed consent in gastroenterology

Abstract

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”.