Collaboration of Experts and Patients to Enhance Informed Consent in Surgery

In an unprecedented move towards patient safety and transparency, leading medical professionals, researchers, legal experts, and patient representatives have teamed up to develop the first comprehensive guide aimed at ensuring patients are fully informed before undergoing innovative or high-risk surgical procedures. This initiative, led by the National Institute for Health and Care Research (NIHR) Bristol Biomedical Research Center and the University of Bristol, culminates in a detailed seven-step framework published in the British Journal of Surgery.

The guide emphasizes the importance of transparent communication, outlining what patients need to know about new surgical techniques, including potential risks, uncertainties, and available alternatives. It also highlights the necessity for surgeons to disclose their experience level and any conflicts of interest.

The complexity of modern surgery, especially with the adoption of novel devices and procedures that lack rigorous regulatory approval processes, calls for standardized consent practices. The framework aims to address systemic failures identified in previous research, where patients were often unaware of the pioneering nature or untested status of certain procedures, such as pelvic mesh implants.

Research has shown that inadequate informed consent can lead to serious patient harm and lasting physical and emotional consequences. Notably, public outcry and investigative inquiries, including the UK’s 'First Do No Harm' review, have shed light on the devastating impact of such oversights, with some women describing their experiences as feeling like unwitting participants in dangerous experiments.

Professor Angus McNair, a key author, explained that this new protocol provides clear guidance for healthcare providers to foster better communication, giving patients a real opportunity to make informed decisions and seek support if complications arise. The initiative also calls for embedding these standards into health services through continuous professional development and accountable organizational policies.

While surgical innovations hold promise for improved treatments, the absence of a formal approval route like that for medicines underscores the importance of transparency and rigorous informed consent. The study’s findings advocate for the global adoption of core standards that balance advancement with patient safety, aiming to prevent future harm and restore trust in surgical innovation.

Future efforts will focus on integrating these core information sets into shared decision-making processes and establishing accountability mechanisms within healthcare systems, ensuring that patient rights and safety remain central to surgical practice.

Source: https://medicalxpress.com/news/2025-07-experts-patients-fully-consenting-surgical.html