B01 - PLENARY: Ethical and Regulatory Considerations for Cutting-Edge Neurotechnology Research

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Recent advances in neurotechnology and artificial intelligence are accelerating clinical trials of brain-computer interfaces and neural implants aimed at restoring speech, movement, and other functions in people with neurological and psychiatric disorders. This includes first-in-human trials enabling individuals with quadriplegia or ALS to control devices with their thoughts. Additional innovations in implantable and non-invasive ultrasound therapies are showing promise for conditions such as depression, OCD, Alzheimer’s, and Parkinson’s disease. However, these breakthroughs raise complex ethical and regulatory challenges. These include assessing device risks (e.g., migration, failure, abandonment, irreversible effects), obtaining informed consent from participants with impaired communication, managing therapeutic misconception, and addressing neuroprivacy concerns. IRBs must also navigate when FDA investigational device regulations apply and whether a device poses significant risk. This session will provide an overview of cutting-edge neurotechnology trials and offer practical guidance for IRBs on evaluating risks, ensuring ethical consent, and making appropriate regulatory determinations.