Ethical Challenges in Early Phase Brain Device Research

Early phase clinical trials investigating novel applications of neural devices, such as deep brain stimulation (DBS) devices, pose ethical challenge during the recruitment of human subjects and in supporting ongoing informed consent over the course of research participation. As these clinical trials end, research participants face complicated decisions about the surgical removal or post-trial use of investigational brain implants. Drawing from qualitative research into the experiences of research participants who have exited from early phase clinical trials in deep brain stimulation, this session will highlight ethical considerations related to participant motivations for enrolling in research, understanding of study procedures at the time of initial informed consent, the process of exiting from research, decisions about device removal or post-trial device use, and concerns about access to long-term follow-up care. Ethical safeguards and approaches to involving ethicists in the earliest stages of clinical research will be proposed. This presentation will also reflect upon the development of evidence-based guidelines to support best practices in informed consent and robust standards for the ethical design and conduct of early phase clinical trials in DBS and other implanted brain devices.

Learning Objectives:
1. Enhance awareness and understanding of ethical challenges that arise in early phase brain device research.
2.Describe practical and ethical challenges in obtaining initial and ongoing informed consent to early phase research participation.
3.Reflect on ethical safeguards that should be in place and the role of ethicists in supporting best practices in brain device research.