Ethical Approaches to Informed Consent for Autonomous Robotic Assisted Surgery

Vanderbilt University, Nashville TN

Investigators

Abstract

PROJECT ABSTRACT Surgery is on the verge of a paradigm shift towards autonomous robot-assisted surgeries (RAS). Increasingly, RAS is incorporating artificial intelligence (AI) algorithms to automate parts of surgery, allowing computer algorithms to make critical decisions during surgery and directly affecting patient care. Autonomous RAS raises new ethical concerns relating to changes to surgeons’ professional autonomy, informed consent, confidentiality/privacy, and the surgeon-patient relationship. The use of autonomous RAS transforms surgeons’ professional autonomy in the operating room by introducing an independent entity in surgical decision-making. The surgeon’s role shifts from being the principal decision-maker to collaborating with the robot or providing oversight of the robot’s actions. Informed consent to autonomous RAS requires new ethical deliberations and information disclosures given that the robot may be making critical decisions during surgery. New ethical issues, including protecting the privacy of RAS-collected patient data, will need to be added in informed consent discussions for autonomous RAS to ensure the surgeon-patient relationship remains human-centered. Although no RAS is fully autonomous today, surgical robots are being endowed with increasing levels of autonomy. Ethical guardrails and guidelines on how to inform patients about autonomous RAS must be in place before autonomous RAS should be disseminated for widespread use. While the few available studies found that patients may be “apprehensive” about undergoing autonomous RAS, little is known about the factors shaping patients’ decision-making. A survey study of 11,004 American adults found that 59% would not want AI-powered robots to be used in their own surgery. Further, no empirical studies have investigated patients’ information needs to facilitate informed consent for the adoption of this innovative surgical technique. The objective of this study is to examine ethical issues in autonomous RAS. We will examine surgeons’ and patients’ perceptions of ethical issues involved in performing and undergoing autonomous RAS, and factors affecting patients’ decisions about undergoing autonomous RAS. We will develop educational materials to facilitate surgeon-patient communication about autonomous RAS and the management of surgeon-patient relationships throughout pre-, intra-, and post-robotic care. The specific aims are to: 1) Assess surgeons’, proceduralists’, and nurses’ perceptions of ethical issues in autonomous RAS 2) Assess surgical patients’ decision-making for undergoing autonomous RAS 3) Develop educational materials to foster patients’ informed decisions about autonomous RAS The impact of the proposed study will be a better understanding of ethical issues of autonomous RAS to facilitate surgeon-patient communication and ensure that the surgeon-patient relationship remains human- centered. Our results will facilitate the adoption of innovative surgical techniques through autonomous RAS.