A Benefit-Risk Framework for Brain Computer Interfaces: A User Centric Communication Method for Informed Decision Making

 In this dissertation, we study the complex realm of Brain-Computer Interfaces (BCIs),  with a focus on their development, regulatory frameworks, and the critical role of user comprehension in understanding their benefits and risks. BCIs, positioned at the  forefront of technological innovation, hold the potential to revolutionize lives on a scale  unprecedented by current technologies. 

We begin with defining BCIs and assessing their current developmental status,  emphasizing those forms most likely to soon enter the market and spotlighting key  developers in this field. 

Chapter 2 navigates the intricate regulatory landscape governed by the US Food and  Drug Administration (FDA). We analyze FDAs regulatory documents, distilling the most  pertinent ones for BCI regulation. Special attention is given to the Investigational Device  Exemption (IDE) and Pre-Market Approval (PMA) processes, vital for assuring the  safety and efficacy of implanted BCIs. 

The heart of this study addresses the shortcomings in the FDA's standardized benefit risk communication methods. We advocate for the adaptation of the Benefit-Risk  Framework (BRF), traditionally employed in drug and biologic assessments, to the  medical device domain. This proposed application aims to refine communication among  developers, regulators, and end-users, ensuring comprehensive understanding of BCIs  benefits and risks. 

We introduce a hypothetical BCI device, reflective of those in current clinical trials, to  craft a BRF through an expert elicitation process. This BRF seamlessly integrates  medical insights with user-centric considerations, offering a holistic view of the  hypothetical device's impact. 

Employing a decision science approach, particularly informed choice theories, we  analyze user responses to various summaries of the BCI and its BRF. Using order-constrained methods, we examine specific hypotheses. Our findings indicate that while  the BRF bolsters knowledge of and positivity toward the BCI, the decision to adopt  depends more on personal feelings than information depth or amount of knowledge  about it.

 We conclude by highlighting the scientific contributions and policy implications of our  study. This research emphasizes the necessity of a multidisciplinary approach in BCI  development, bridging the gap between technical innovation and user-centric  understanding.