Informed consent: more than just a signature

Informed consent: more than just a signature
Parker O’Neill, Sierra Schaffer, Fallon O’Neill, Andrew Poullis
Gut, 19 June 2022; 71
Informed consent is a core component of ethical medical practice and is vital to ensure patient autonomy is upheld. However, consent is not a static concept and physicians need to remain engaged with the literature to ensure they minimise their liability. This study aims to clarify the legal duties of gastroenterologists when gaining informed consent by analysing the current literature and past legal precedents.
A bibliometric analysis of the Web of Science (WoS) Core Collection database was performed with the MeSH terms ‘gastroenterology’ AND ‘informed consent’. The top 50 most-cited articles were extracted and analysed. A scoping review was performed of the case law surrounding informed consent in the UK and the USA.
A total of 383 articles were identified on the WoS, with 228 articles excluded due to not meeting the inclusion criteria. of the top 50 articles, 48% were from American institutions and 16% were from the UK. The American Journal of Gastroenterology had published 20% and the Journal of Digestive Diseases had published 8% of the top 50 articles. Since 1970, there has been a steady rise in citations of articles pertaining to informed consent in gastroenterology with the record of 63 citations occurring in 2015. Thematic analysis showed 72% of the top 50 articles discussed informed consent in relation to diagnostic procedures, 14% regarding treatment, and 14% regarding research participation. of the articles discussing diagnostic procedures, half specified the type of diagnostic tool evaluated. Thirty-three percent of articles focused on colonoscopy, 26% on OGD, 22% on ERCP, 11% on flexible sigmoidoscopy, and 7% on genetic testing. The UK has progressed from what was previously a paternalistic Bolam’s test with the Bolitho addendum to the Montgomery test 2015 which demands physicians establish what is relevant to their specific patient when gaining informed consent. The USA experienced a similar evolution, progressing from the Natanson case holding physicians to the standard of a ‘reasonable and prudent medical doctor’ to the Canterbury case 1972 requiring physicians to disclose what would be important to a ‘reasonable patient’. Exponentially more articles have been published since the American Canterbury case came into effect. Most articles focused on invasive procedures and discussed complex ethical questions seeking to increase patient autonomy.
Physicians in both the UK and USA now have a legal duty to ensure their patients are fully informed to a standard that their individual patient deems appropriate. Most articles published are American-based and focus on informed consent in the context of diagnostic colonoscopy. Physicians may benefit from international guidelines on consenting patients for invasive procedures in gastroenterology.

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