Practical Issues and Governance Implications of Ethical Review in High-Risk Technological Activities – Taking the Invasive Brain-Computer Interface Project in Shanghai as an Example

Based on the review of five brain-computer interface projects in Shanghai, it was analyzed that the main issues identified during the second round of reviews were related to the adequacy of preclinical evidence, the feasibility of research protocols, compliance with regulations regarding innovative devices and research approaches, risks associated with complex systems, misunderstandings regarding therapeutic purposes in informed consent processes, and long-term rights and obligations related to implanted devices. Some of these issues were not completely overlooked during the initial review. The focus of the second round of reviews was to determine whether the existing scientific evidence was sufficient to justify the scientific and ethical justification for conducting human trials. Ethical reviews of high-risk technologies should emphasize a more rigorous evaluation of the scientific aspects, shifting from a mere examination of individual technologies to a more comprehensive assessment of overall ethical considerations.