随着神经技术的快速发展，越来越多患者参与脑机接口和神经植入的临床试验。12024年，Neuralink进行了首次人类脑植入手术，目前已有20多名"神经宇航员"使用植入物参与在线活动。1与此同时，英国研究人员展示志愿者可以同时控制机器肢体和自然肢体，1澳大利亚EpiMinder公司获得FDA授权销售癫痫监测系统，而Synchron公司则筹集超过3亿澳元用于脑机接口开发。1
然而，这些技术进步面临一个关键问题：当临床试验结束后，参与者的长期设备支持与护理如何保障。1澳大利亚目前缺乏相关规则确保试验后的持续护理，尽管澳大利亚临床试验手册要求研究人员"清楚解释"参与者是否获得持续访问权，但这一要求在实践中难以实现。1
为解决这一困境，由澳大利亚研究团队汇集的24名临床医生、生物工程师、伦理学家等专家制定了相关建议框架。1该建议包括向参与者说明持续使用的现实情况、提供资金与监管状态的定期更新，以及预先解决地理和社会经济障碍。1
As neural implant technology advances, increasing numbers of patients are enrolling in clinical trials for brain-computer interfaces. In 2024, Neuralink performed its first human brain implant surgery, with more than 20 "neural astronauts" now using implants to participate in online activities 1. British researchers have also demonstrated that volunteers can simultaneously control both robotic and natural limbs 1. Meanwhile, Australia's EpiMinder company received FDA authorization to sell an epilepsy monitoring system, and Synchron raised over 300 million Australian dollars for brain-computer interface development 1.
However, a critical gap exists in current regulatory frameworks. Australia currently lacks rules requiring trial organizers to provide long-term participant support after studies conclude 1. While the Australian Clinical Trial Handbook requires researchers to "clearly explain" whether participants will have continued access to implants, this standard proves difficult to implement in practice 1.
In response, a research team comprising 24 clinical doctors, bioengineers, ethicists, and other experts has developed recommendations to address this gap 1. Their proposals include providing participants with realistic expectations about sustained use, delivering regular updates on funding and regulatory status, and proactively resolving geographic and socioeconomic barriers to access 1. These recommendations aim to establish a comprehensive framework ensuring that participants receive appropriate support once their clinical trials conclude 1.
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