A proposed ethical framework for informed consent in elective robotic telesurgery

关于择期机器人远程手术知情同意的伦理框架提案

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Abstract

Guidelines for informed consent (IC) in telesurgery are not well-defined. Ethical frameworks for clinic innovation generally focus on four key concerns, IC, safety/efficacy, patient vulnerability and conflicts of interest. The purpose of this paper is to review published recommendations on IC for telesurgery and create an ethics framework for elective telesurgical IC. A scoping literature review was performed using search terms Telesurg* AND (guideline OR consensus) in PubMed, Web of Science, and SCOPUS databases. Full text English language articles published by December 18, 2025 were included. Manuscripts were excluded if clinical telesurgery was not the subject or no formal recommendations were made regarding the IC process. A ethics framework for IC was developed based on relevant literature. 83 articles were reviewed and 4 relevant manuscripts were identified. An ethics framework for IC is proposed based on the available literature and can be further adapted regionally. A local and virtual interactive multi-stage consent process is suggested. A structured disclosure approach with key elements is outlined. Relevant terminology is defined, including implicit and explicit (situational, surgeon-specific and shared responsibility) disclosure elements. IC with disclosure of situational, local and remote surgeon-specific elements, and any shared accountability is the best practice standard for elective telesurgical consent. A multi-stage local and virtual interactive consent process should be offered in an opt-out fashion.

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