Brain Stimulation (Sep 2024)
Where is the exit? The ethical importance of exit plans in clinical trials with neural implants
Abstract
Background: As clinical trials involving implantable neural devices (INDs) increase in frequency and attract greater public attention, it is paramount to ensure they are conducted in alignment with fundamental ethical guidelines. Particular focus must be placed on the often underexplored aspect of trial termination for INDs. Objective: To systematically review the ethical challenges encountered in clinical trials for INDs at the juncture of trial termination. Methods: We conducted a rapid review using PubMed with two specific search queries, including all publications addressing ethical issues in the context of IND clinical trials. Priority was given to publications focusing on the end of treatment or the discontinuation of clinical studies or trials. Results: We identified three primary groups of ethical challenges: patient-centric challenges, challenges faced by the research and physician team, and manufacturer-related issues. Further analysis highlights the importance of initiating early, transparent discussions regarding trial cessation protocols, ensuring that all stakeholders—patients, healthcare providers, researchers, and manufacturers—are equitably considered. Additionally, we found a discrepancy between current discontinuation strategies and international ethical guidelines. To address this, we emphasize the ethical obligation to establish comprehensive exit strategies that align with the principles in the Declaration of Helsinki and the CIOMS/WHO guidelines. Conclusion: Our findings highlight the need for increased attention to the ethical and practical aspects of exit strategies and encourage further empirical research to address gaps in current practices. This would ensure that the discontinuation of IND trials is handled with ethical rigor, prioritizing the interests and well-being of all stakeholders involved.
